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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K933742
Device Name TOP GUN
Applicant
Bio-Medical Devices, Inc.
1752-A Langley Ave.
Irvine,  CA  92614
Applicant Contact NICK HERBERT
Correspondent
Bio-Medical Devices, Inc.
1752-A Langley Ave.
Irvine,  CA  92614
Correspondent Contact NICK HERBERT
Regulation Number880.5475
Classification Product Code
FQH  
Date Received08/03/1993
Decision Date 04/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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