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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K102752
Device Name STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
Applicant
Stingray Surgical Products, Inc.
801 Apple Tree Ln.
Boca Raton,  FL  33486
Applicant Contact MARK MCBRINN
Correspondent
Stingray Surgical Products, Inc.
801 Apple Tree Ln.
Boca Raton,  FL  33486
Correspondent Contact MARK MCBRINN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/23/2010
Decision Date 11/09/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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