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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K950646
Device Name INTEGRATOR
Applicant
Moyco Union Broach, Div., Moyco Technologies, Inc.
589 Davies Dr.
York,  PA  17402
Applicant Contact CHRIS M LEHR
Correspondent
Moyco Union Broach, Div., Moyco Technologies, Inc.
589 Davies Dr.
York,  PA  17402
Correspondent Contact CHRIS M LEHR
Classification Product Code
LXM  
Date Received02/13/1995
Decision Date 04/30/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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