PRIMAGARD Isolation Gown (AAMI PB70 Level 3)— 510(k) K160361

Substantially Equivalent

Primed 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..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code FYC
Advisory panel: General, Plastic Surgery
Date received: 2016-02-09
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

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