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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K991037
Device Name EUCLID REDUCTION AND GUIDANCE SYSTEM
Applicant
Modular Cutting Systems, Inc.
650 Clinton Ave.
Bridgeport,  CT  06605
Applicant Contact ALLEN P SCHLEIN
Correspondent
Modular Cutting Systems, Inc.
650 Clinton Ave.
Bridgeport,  CT  06605
Correspondent Contact ALLEN P SCHLEIN
Regulation Number888.3030
Classification Product Code
JDS  
Date Received03/29/1999
Decision Date 06/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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