PRIMAGARD Isolation Gown (AAMI PB70 Level 3)— 510(k) K160361
Substantially EquivalentPrimed Medical Products, Inc.
FDA 510(k) clearance K160361 for PRIMAGARD Isolation Gown (AAMI PB70 Level 3), Substantially Equivalent on 2016-11-04. Applicant: Primed Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Primed Medical Products, Inc.
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edmonton, CA
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More 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
- K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K240286 — PRIMED Surgical Masks and PRIMED Procedure Masks
Data sourced from openFDA. This site is unofficial and independent of the FDA.