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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 K851257
Device Name CRS ULTRALITE PREMIER
Applicant
Everest & Jennings, Inc.
3233 E Mission Oaks Blvd.
Camarillo,  CA  93010
Applicant Contact MOLINELLI
Correspondent
Everest & Jennings, Inc.
3233 E Mission Oaks Blvd.
Camarillo,  CA  93010
Correspondent Contact MOLINELLI
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/28/1985
Decision Date 06/28/1985
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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