The following data is part of a premarket notification filed by Custom Sterile Services, Inc. with the FDA for Reusable Towel And Gown Packs.
| Device ID | K930167 |
| 510k Number | K930167 |
| Device Name: | REUSABLE TOWEL AND GOWN PACKS |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | CUSTOM STERILE SERVICES, INC. 711 - 78TH AVENUE SW Tumwater, WA 98501 |
| Contact | Rod Powell |
| Correspondent | Rod Powell CUSTOM STERILE SERVICES, INC. 711 - 78TH AVENUE SW Tumwater, WA 98501 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-13 |
| Decision Date | 1993-11-30 |