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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 K972037
Device Name PROWLER
Applicant
The Buzzz Corp.
213 E. Luzerne Ave.
Larksville,  PA  18704
Applicant Contact KEN CASEY
Correspondent
The Buzzz Corp.
213 E. Luzerne Ave.
Larksville,  PA  18704
Correspondent Contact KEN CASEY
Regulation Number890.3800
Classification Product Code
INI  
Date Received06/02/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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