PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)— 510(k) K242208
Substantially EquivalentPrimed Medical Products, Inc.
FDA 510(k) clearance K242208 for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), Substantially Equivalent on 2024-10-07. Applicant: Primed Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Primed Medical Products, Inc.
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, CA
Recent devices under product code FRG
view allMore clearances from Primed Medical Products, Inc.
view all- K262007 — PRIMED AAMI Level 3 Open Back Gowns
- K261811 — PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2 +1 more
- K252964 — PRIMED Surgical and Procedure Masks
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
- K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Adverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
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.