The following data is part of a premarket notification filed by Stingray Surgical Products, Inc with the FDA for Stingray Electrosurgical Forceps.
Device ID | K083162 |
510k Number | K083162 |
Device Name: | STINGRAY ELECTROSURGICAL FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STINGRAY SURGICAL PRODUCTS, INC PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm STINGRAY SURGICAL PRODUCTS, INC PO BOX 7007 Deerfield, IL 60015 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-27 |
Decision Date | 2009-01-12 |
Summary: | summary |