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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wheelchair, standup
510(k) Number K921894
Device Name RIFTON MOBILE PRONE STANDERS
Applicant
RIFTON EQUIPMENT FOR THE HANDICAPPED
55 NORTHERN BLVD.
SUIT 301
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
RIFTON EQUIPMENT FOR THE HANDICAPPED
55 NORTHERN BLVD.
SUIT 301
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number890.3900
Classification Product Code
IPL  
Date Received04/22/1992
Decision Date 05/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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