The following data is part of a premarket notification filed by Clearcount Medical Solutions with the FDA for Smartwand-dtx.
| Device ID | K093557 |
| 510k Number | K093557 |
| Device Name: | SMARTWAND-DTX |
| Classification | Counter, Sponge, Surgical |
| Applicant | CLEARCOUNT MEDICAL SOLUTIONS 101 BELLEVUE RD., 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 | 2009-11-16 |
| Decision Date | 2009-12-18 |
| Summary: | summary |