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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K935836
Device Name BONE OR INTERFERENCE SCREW
Applicant
Endo Surgical Concepts, Inc.
51 Rambling Brook Rd.
Chappaqua,,  NY  10514
Applicant Contact ALAN A SMALL
Correspondent
Endo Surgical Concepts, Inc.
51 Rambling Brook Rd.
Chappaqua,,  NY  10514
Correspondent Contact ALAN A SMALL
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/07/1993
Decision Date 04/15/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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