PRIMED SHOE COVERS, PRIMED HEAD COVERS— 510(k) K971076
Substantially EquivalentPrimeline Medical Products, Inc.
FDA 510(k) clearance K971076 for PRIMED SHOE COVERS, PRIMED HEAD COVERS, Substantially Equivalent on 1998-01-13. Applicant: Primeline Medical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Primeline Medical Products, Inc.
- Product code
- Code FXP
- Device class
- Class 1
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alberta, CA
Recent devices under product code FXP
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- K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
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