The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Resheather Device-metal Or Plastic, Resheater/ Needle Holder Device-plastic.
| Device ID | K972705 |
| 510k Number | K972705 |
| Device Name: | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1998-04-30 |
| Summary: | summary |