The following data is part of a premarket notification filed by Gri-alleset, Inc with the FDA for Comfortguard Surgical Isolation Gown.
| Device ID | K210131 |
| 510k Number | K210131 |
| Device Name: | ComfortGuard Surgical Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | GRI-Alleset, Inc 4142 Industry Way Flowery Branch, GA 30542 |
| Contact | Marty D Paugh |
| Correspondent | Harry L. Shaffer Sterilization Consulting Services, LLC 7302 Kinglet Ct Katy, TX 77493 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26931918190652 | K210131 | 000 |
| 26931918165919 | K210131 | 000 |
| 26931918129225 | K210131 | 000 |