MACROPORE SURGICAL BARRIER FILM


Device Classification Name

wrap, implant, orbital

510(k) Number K023643
Device Name MACROPORE SURGICAL BARRIER FILM
Original Applicant
MACROPORE BIOSURGERY, INC.
6740 top gun st.
san diego, 
CA 
92121

Original Contact kenneth k kleinhenz
Regulation Number 886.3320
Classification Product Code
MTZ  
Date Received 10/30/2002
Decision Date 02/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No