The following data is part of a premarket notification filed by Stingray Surgical Products, Inc with the FDA for Stingray Ultralite Disposable Irrigating Bipolar Forceps.
Device ID | K102752 |
510k Number | K102752 |
Device Name: | STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | STINGRAY SURGICAL PRODUCTS, INC 801 APPLE TREE LANE Boca Raton, FL 33486 |
Contact | Mark Mcbrinn |
Correspondent | Mark Mcbrinn STINGRAY SURGICAL PRODUCTS, INC 801 APPLE TREE LANE Boca Raton, FL 33486 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-23 |
Decision Date | 2011-11-09 |
Summary: | summary |