The following data is part of a premarket notification filed by Michael Fischer Assoc. with the FDA for Sponge Count.
| Device ID | K945144 |
| 510k Number | K945144 |
| Device Name: | SPONGE COUNT |
| Classification | Counter, Sponge, Surgical |
| Applicant | MICHAEL FISCHER ASSOC. 1248 PINE ST. Winnetka, IL 60093 |
| Contact | Michael Fischer |
| Correspondent | Michael Fischer MICHAEL FISCHER ASSOC. 1248 PINE ST. Winnetka, IL 60093 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1995-01-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPONGE COUNT 74518679 not registered Dead/Abandoned |
Fischer, Michael 1994-04-29 |