FDA 510(k) Applications Submitted by PRIMED MEDICAL PRODUCTS INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240286 |
02/01/2024 |
PRIMED Surgical Masks and PRIMED Procedure Masks |
Primed Medical Products Inc. |
| K242208 |
07/29/2024 |
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) |
PRIMED Medical Products Inc. |
| K213427 |
10/21/2021 |
PRIMED Pediatric Facemask |
PRIMED Medical Products Inc. |
| K233777 |
11/24/2023 |
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) |
PRIMED Medical Products Inc. |
| K092012 |
07/06/2009 |
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 |
PRIMED MEDICAL PRODUCTS INC. |
| K081633 |
06/11/2008 |
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS |
PRIMED MEDICAL PRODUCTS INC. |
| K160361 |
02/09/2016 |
PRIMAGARD Isolation Gown (AAMI PB70 Level 3) |
PRIMED MEDICAL PRODUCTS INC. |
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