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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Oral
510(k) Number K936050
Device Name JAW SPREADER
Applicant
Gam Industries, Inc.
P.O. Box 2226
Petersburg,  VA  23804
Applicant Contact GARY J BEDEN
Correspondent
Gam Industries, Inc.
P.O. Box 2226
Petersburg,  VA  23804
Correspondent Contact GARY J BEDEN
Regulation Number874.4420
Classification Product Code
KBW  
Date Received12/20/1993
Decision Date 03/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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