The following data is part of a premarket notification filed by Clearcount Medical Solutions, Inc. with the FDA for Smartsponge System.
| Device ID | K071355 |
| 510k Number | K071355 |
| Device Name: | SMARTSPONGE SYSTEM |
| Classification | Counter, Sponge, Surgical |
| Applicant | CLEARCOUNT MEDICAL SOLUTIONS, INC. 700 RIVER AVE., SUITE 100 Pittsburgh, PA 15212 |
| Contact | Steven Fleck |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-15 |
| Decision Date | 2007-05-24 |
| Summary: | summary |