PERMARIDGE HYDROXYLAPATITE MATRIX


Device Classification Name

prosthesis, chin, internal

510(k) Number K960349
Device Name PERMARIDGE HYDROXYLAPATITE MATRIX
Applicant
CERAMED CORP.
12860 west cedar dr., ste. 110
lakewood, 
CO 
80228

Applicant Contact barbara a watson
Correspondent
CERAMED CORP.
12860 west cedar dr., ste. 110
lakewood, 
CO 
80228

Correspodent Contact barbara a watson
Regulation Number 878.3550
Classification Product Code
FWP  
Date Received 01/25/1996
Decision Date 03/13/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No