OCU-GUARD AND OCU-GUARD SUPPLE— 510(k) K983581
Substantially EquivalentBio-Vascular, Inc.
FDA 510(k) clearance K983581 for OCU-GUARD AND OCU-GUARD SUPPLE, Substantially Equivalent on 1998-11-06. Applicant: Bio-Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Vascular, Inc.
- Product code
- Code HQX
- Device class
- Class 2
- Regulation
- 21 CFR 886.3340
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
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- K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
- K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN)
More clearances from Bio-Vascular, Inc.
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- K983602 — CV PERI-GUARD AND VASCU-GUARD
- K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
- K981624 — FLO-THRU
Data sourced from openFDA. This site is unofficial and independent of the FDA.