PROCEDURE MASKS: PM4-301 AND PM4-304— 510(k) K011789
Substantially EquivalentPrimeline Medical Products, Inc.
FDA 510(k) clearance K011789 for PROCEDURE MASKS: PM4-301 AND PM4-304, Substantially Equivalent on 2001-06-22. Applicant: Primeline Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Primeline Medical Products, Inc.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Edmonton, Alberta, CA
Recent devices under product code FXX
view all- K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more
- K252534 — Surgical Face Mask (Ear mount)
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
More clearances from Primeline Medical Products, Inc.
view all- K022868 — PRIMAGARD SURGICAL EQUIPMENT DRAPES
- K023117 — PRIMAGARD SURGICAL GOWNS
- 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
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.