GUARDIAN SURGEON'S GOWNS
Gown, Surgical
ATKINS HEALTHCARE SERVICES
The following data is part of a premarket notification filed by Atkins Healthcare Services with the FDA for Guardian Surgeon's Gowns.
Pre-market Notification Details
| Device ID | K931562 |
| 510k Number | K931562 |
| Device Name: | GUARDIAN SURGEON'S GOWNS |
| Classification | Gown, Surgical |
| Applicant | ATKINS HEALTHCARE SERVICES 4320 INTERNATIONAL BLVD., N.W. Norcross, GA 30093 -3017 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1994-10-07 |
NIH GUDID Devices
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