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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, manual, specialized obstetric-gynecologic
510(k) Number K941641
Device Name DISPOSABLE EMERGENCY OBSTETRICAL KIT
Applicant
GAM INDUSTRIES, INC.
P.O. BOX 2226
PETERSBURG,  VA  23804 -1526
Applicant Contact GARY J BEDEN
Correspondent
GAM INDUSTRIES, INC.
P.O. BOX 2226
PETERSBURG,  VA  23804 -1526
Correspondent Contact GARY J BEDEN
Regulation Number884.4530
Classification Product Code
KNA  
Date Received04/04/1994
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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