The following data is part of a premarket notification filed by Encompass Group, Llc. with the FDA for Rotecno Fr (fluid Resistant) Surgical Gown.
| Device ID | K982058 |
| 510k Number | K982058 |
| Device Name: | ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | ENCOMPASS GROUP, LLC. 615 MACON RD. Mcdonough, GA 30253 |
| Contact | Tim Cummins |
| Correspondent | Tim Cummins ENCOMPASS GROUP, LLC. 615 MACON RD. Mcdonough, GA 30253 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-11 |
| Decision Date | 1999-01-14 |
| Summary: | summary |