VENTIL-A ORAL PROTECTOR


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

Correspodent Contact richard abrams
Regulation Number 882.5070
Classification Product Code
JXL  
Date Received 07/06/1999
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

Category: Uncategorized