IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP


Device Classification Name

mesh, surgical, polymeric

510(k) Number K024199
Device Name IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
Original Applicant
OSTEOBIOLOGICS, INC.
university business park
12500 network, suite 112
san antonio, 
TX 
78249 -3308

Original Contact gabriele g niederauer
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 12/20/2002
Decision Date 03/14/2003
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