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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 K982607
Device Name MANUAL WHEELCHAIR
Applicant
G. Hirsch and Co., Inc.
1815 Rollins Rd.
Burlingame,  CA  94010
Applicant Contact GARY HIRSCH
Correspondent
G. Hirsch and Co., Inc.
1815 Rollins Rd.
Burlingame,  CA  94010
Correspondent Contact GARY HIRSCH
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/27/1998
Decision Date 08/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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