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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K921946
Device Name TUM-E-VAC BITE BLOCK
Applicant
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Applicant Contact ROBERT J HEIN
Correspondent
Ethox Corp.
251 Seneca St.
Buffalo,  NY  14204
Correspondent Contact ROBERT J HEIN
Regulation Number882.5070
Classification Product Code
JXL  
Date Received04/27/1992
Decision Date 12/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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