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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wheelchair, Powered
510(k) Number K943789
Device Name POWER WHEELCHAIR CONVERSION KIT
Applicant
Alber Technologies, Inc.
C/O Arent/Fox/Kinter/Plot/Kahn
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Applicant Contact MINDY L KLASKY
Correspondent
Alber Technologies, Inc.
C/O Arent/Fox/Kinter/Plot/Kahn
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Correspondent Contact MINDY L KLASKY
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/03/1994
Decision Date 11/08/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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
Recalls CDRH Recalls
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