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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K932795
Device Name HAVERICH ORTHOPAEDIC CYCLES
Applicant
Haverich Ortho-Sport (Usa), Inc.
67 Emerald St.
Suite 385
Keene,  NH  03431
Applicant Contact BENEKE JR.
Correspondent
Haverich Ortho-Sport (Usa), Inc.
67 Emerald St.
Suite 385
Keene,  NH  03431
Correspondent Contact BENEKE JR.
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/09/1993
Decision Date 07/22/1993
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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