510(k) K023643
- Device
- MACROPORE SURGICAL BARRIER FILM
- Applicant
- MACROPORE BIOSURGERY, INC.
- 510(k) number
- K023643
- Product code
- MTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-02-21
- Date received
- 2002-10-30
- Regulation
- 886.3320
- Classification name
- Wrap, Implant, Orbital
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH K KLEINHENZ
- Address
- 6740 Top Gun St. San Diego CA US 92121 92121
Source Documents#
Other 510(k) Records For Product Code MTZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Bio-Vascular, Inc. | 1997-12-16 |
Legacy Summary#
summary
FDA Review#
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