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 |