The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Surgical Sponge Scanner.
| Device ID | K061316 |
| 510k Number | K061316 |
| Device Name: | MEDLINE SURGICAL SPONGE SCANNER |
| Classification | Counter, Sponge, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-11 |
| Decision Date | 2006-11-02 |