510(k) K973552
- Device
- OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
- Applicant
- BIO-VASCULAR, INC.
- 510(k) number
- K973552
- Product code
- MTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-16
- Date received
- 1997-09-19
- 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
- JULIE SHERMAN
- Address
- 2575 University Ave. St. Paul MN US 55114 55114
Source Documents#
Other 510(k) Records For Product Code MTZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023643 | MACROPORE SURGICAL BARRIER FILM | Macropore Biosurgery, Inc. | 2003-02-21 |
Legacy Summary#
summary
FDA Review#
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