The following data is part of a premarket notification filed by Primed Medical Products Inc. with the FDA for Primagard Isolation Gown (aami Pb70 Level 3).
| Device ID | K160361 |
| 510k Number | K160361 |
| Device Name: | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) |
| Classification | Gown, Isolation, Surgical |
| Applicant | PRIMED MEDICAL PRODUCTS INC. 3RD FLOOR, 1259-91 ST SW. Edmonton, CA T6x1e9 |
| Contact | Richard R Roy |
| Correspondent | Richard R Roy PRIMED MEDICAL PRODUCTS INC. 3RD FLOOR, 1259-91 ST SW. Edmonton, CA T6x1e9 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813360023046 | K160361 | 000 |