The following data is part of a premarket notification filed by Ritmed, Inc. with the FDA for Countway Sys. Soiled Sponges-blood Los.
| Device ID | K830273 |
| 510k Number | K830273 |
| Device Name: | COUNTWAY SYS. SOILED SPONGES-BLOOD LOS |
| Classification | Scale, Surgical Sponge |
| Applicant | RITMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FQA |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-25 |
| Decision Date | 1983-02-28 |