The following data is part of a premarket notification filed by Stingray Surgical Products with the FDA for Stingray Bipolar Forceps.
Device ID | K123478 |
510k Number | K123478 |
Device Name: | STINGRAY BIPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STINGRAY SURGICAL PRODUCTS 156 NW 16th St Boca Raton, FL 33432 |
Contact | Mark Mcbrinn |
Correspondent | Mark Mcbrinn STINGRAY SURGICAL PRODUCTS 156 NW 16th St Boca Raton, FL 33432 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-13 |
Decision Date | 2013-05-10 |
Summary: | summary |