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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K893429
Device Name ALPHA CONDOR
Applicant
Alpha Unlimited, Inc.
1610 Northgate Blvd.
Sarasota,  FL  34234
Applicant Contact L PETERSON
Correspondent
Alpha Unlimited, Inc.
1610 Northgate Blvd.
Sarasota,  FL  34234
Correspondent Contact L PETERSON
Regulation Number890.3800
Classification Product Code
INI  
Date Received05/02/1989
Decision Date 06/12/1989
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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