The following data is part of a premarket notification filed by Surgicount Medical with the FDA for Surgicount Safety-sponge System.
| Device ID | K060076 |
| 510k Number | K060076 |
| Device Name: | SURGICOUNT SAFETY-SPONGE SYSTEM |
| Classification | Counter, Sponge, Surgical |
| Applicant | SURGICOUNT MEDICAL 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell SURGICOUNT MEDICAL 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-10 |
| Decision Date | 2006-03-14 |
| Summary: | summary |