AFP MANUFACTURING, INC.

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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

Processor, Radiographic-Film, Automatic (IXW) (1) Processor, Radiographic-Film, Automatic, Dental (EGY) (1)

Premarket Exempt

Yes

Clear

AFP 810 - B580EGY0 Catalog Number : 2001

Device Description : x-ray film processor, dental

Device Class : 2

Duns Number: 080326963

Premarket Exempt : Yes

Product Code : EGY

Prescription Use : No

Device Count : 1

Mini Med - B580IWX0 Catalog Number : 1001

Device Description : x-ray film processor, Medical

Device Class : 2

Duns Number: 080326963

Premarket Exempt : Yes

Product Code : IXW

Prescription Use : No

Device Count : 1

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