COMPOSITE MANUFACTURING, INC.

Address:970 B Calle Amanecer,San Clemente,CA,92673,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Retractor (GAD) (2) Table And Attachments, Operating-Room (BWN) (2) Post Breast Biopsy Hemostatic Breast Compression Device (POY) (1)

Premarket Exempt

No Yes

Clear

Microsurgical Arm and Hand Table with 4 inch Pad - 00810105030495 Catalog Number :

Device Description : Surgical support table with stabilizing leg and surgeon elbow rests. This device Surgical support table with stabilizing leg and surgeon elbow rests. This device attaches to a surgical tables side rails via an accessory clamp.

Device Class : 1

Duns Number: 947090650

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Xpress BCD Breast Compression Device - 00810105030501 Catalog Number :

Device Description : The proposed device, the XPress BCD, is used in conjunction stereotactic breast The proposed device, the XPress BCD, is used in conjunction stereotactic breast biopsy devices. The primary function of the device is to provide effective consistent mechanical breast compression following stereotactic-guided biopsy, replacing standard manual compression of post breast biopsy sites. Reliable and effective mechanical breast compression, with equivalent clinical outcomes, reduces medical staff blood exposure and allows for significant labor savings.

Device Class : 2

Duns Number: 947090650

Premarket Exempt : No

Product Code : POY

Prescription Use : Yes

Device Count : 1

Buxton Wrist Retractor Blade, 30mm Assy, Net - 00810105030518 Catalog Number :

Device Description : 30mm x 30mm radiolucent carbon fiber retractor

Device Class : 1

Duns Number: 947090650

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Buxton Wrist Retractor Blade, 15mm Assy, Net - 00810105030525 Catalog Number :

Device Description : 30mm x 15mm radiolucent carbon fiber retractor

Device Class : 1

Duns Number: 947090650

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Anesthesia Armboard without Pad - 00810105030532 Catalog Number :

Device Description : Carbon Fiber construction Armboard designed to integrate with surgical table sid Carbon Fiber construction Armboard designed to integrate with surgical table side rail and support the patient armfor surgical procedures.

Device Class : 1

Duns Number: 947090650

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

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