PRIMAGARD SURGICAL GOWNS— 510(k) K023117
Substantially EquivalentPrimeline Medical Products, Inc.
FDA 510(k) clearance K023117 for PRIMAGARD SURGICAL GOWNS, Substantially Equivalent on 2002-11-08. Applicant: Primeline Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Primeline Medical Products, Inc.
- Product code
- Code KKX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, Alberta, CA
Recent devices under product code KKX
view allMore clearances from Primeline Medical Products, Inc.
view all- K022868 — PRIMAGARD SURGICAL EQUIPMENT DRAPES
- K023266 — PRIMAGARD SURGICAL GOWNS
- K021864 — PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
- K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
- K011789 — PROCEDURE MASKS: PM4-301 AND PM4-304
Data sourced from openFDA. This site is unofficial and independent of the FDA.