The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Pocket Count Or Safetcount.
| Device ID | K972302 |
| 510k Number | K972302 |
| Device Name: | POCKET COUNT OR SAFETCOUNT |
| Classification | Counter, Sponge, Surgical |
| Applicant | SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
| Contact | Karen Pinto |
| Correspondent | Karen Pinto SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake, IL 60014 -8172 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-19 |
| Decision Date | 1997-07-25 |
| Summary: | summary |