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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K924144
Device Name ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
Applicant
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact ROBIN M DRAGO
Correspondent
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact ROBIN M DRAGO
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/18/1992
Decision Date 04/08/1993
Decision Substantially Equivalent (SESE)
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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