Device Classification Name |
wrap, implant, orbital |
|||
---|---|---|---|---|
510(k) Number | K023643 | |||
Device Name | MACROPORE SURGICAL BARRIER FILM | |||
Original Applicant |
|
|||
Original Contact | kenneth k kleinhenz | |||
Regulation Number | 886.3320 | |||
Classification Product Code |
|
|||
Date Received | 10/30/2002 | |||
Decision Date | 02/21/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Ophthalmic |
|||
510k Review Panel |
Ophthalmic |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |