Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap
FDA 510(k) K973552 · Bio-Vascular, Inc.
510(k) numberK973552
Submission
- Device name
- Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- September 19, 1997
- Decision date
- December 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTZ – Wrap, Implant, Orbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code MTZ
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|---|---|---|---|
| K023643 | Macropore Surgical Barrier FilmMTZ · Traditional | Macropore Biosurgery, Inc. | 02/21/2003SE |
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| K983602 | CV Peri-Guard and Vascu-GuardDXZ · Special | 11/12/1998SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | 11/06/1998SE |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special | 10/09/1998SE |
| K981624 | Flo-ThruDXC · Traditional | 08/04/1998SE |
| K982282 | Dura-Guard - Dural Repair PatchGXQ · Special | 07/30/1998SE |
| K971726 | CV Peri-Guard - Cardiovascular PatchDXZ · Traditional | 04/10/1998SE |
| K973706 | Dura-Guard-Dural Repair PatchGXQ · Traditional | 12/24/1997SE |
| K971048 | Peri-Strips Dry - Staple Line ReinforcementFTM · Traditional | 05/09/1997SE |
Questions and answers
When was Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap cleared by the FDA?
Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap (K973552) received a 510(k) decision of Substantially Equivalent on December 16, 1997, 88 days after the submission was received.
What is the product code of K973552?
The FDA product code is MTZ – Wrap, Implant, Orbital, a Class II (moderate risk) device regulated under 21 CFR 886.3320.