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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 K992269
Device Name VENTIL-A ORAL PROTECTOR
Applicant
SOMATICS, INC.
910 SHERWOOD DR., UNIT 17
LAKE BLUFF,  IL  60044
Applicant Contact RICHARD ABRAMS
Correspondent
SOMATICS, INC.
910 SHERWOOD DR., UNIT 17
LAKE BLUFF,  IL  60044
Correspondent Contact RICHARD ABRAMS
Regulation Number882.5070
Classification Product Code
JXL  
Date Received07/06/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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