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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K951028
Device Name HAMEX TWO
Applicant
Northern Orthopaedic Products, Inc.
54 Wakefield St.
Hamden,  CT  06517
Applicant Contact THOMAS L BRADY
Correspondent
Northern Orthopaedic Products, Inc.
54 Wakefield St.
Hamden,  CT  06517
Correspondent Contact THOMAS L BRADY
Regulation Number890.5380
Classification Product Code
BXB  
Date Received03/07/1995
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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