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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 K942607
Device Name LAPAROSCOPIC SCISSORS (DISPOSABLE)
Applicant
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Applicant Contact JACK W HOWARD
Correspondent
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Correspondent Contact JACK W HOWARD
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/01/1994
Decision Date 07/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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