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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 K950195
Device Name KARMA WHEELCHAIR
Applicant
Karman Healthcare, Inc.
9662 E. Rush St.
South El Monte,  CA  91733
Applicant Contact ALEX C HORNG
Correspondent
Karman Healthcare, Inc.
9662 E. Rush St.
South El Monte,  CA  91733
Correspondent Contact ALEX C HORNG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/18/1995
Decision Date 03/07/1995
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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