The following data is part of a premarket notification filed by Clearcount Medical Solutions, Inc. with the FDA for Smartsponge Plus System.
| Device ID | K073180 |
| 510k Number | K073180 |
| Device Name: | SMARTSPONGE PLUS SYSTEM |
| Classification | Counter, Sponge, Surgical |
| Applicant | CLEARCOUNT MEDICAL SOLUTIONS, INC. 101 BELLEVUE ROAD SUITE 300 Pittsburgh, PA 15229 |
| Contact | Jeff Wolfgong |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2007-11-19 |
| Summary: | summary |