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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Bite Block
510(k) Number K931044
Device Name OXY-BLOC
Applicant
Gi Supply
423n. 21st St.
Camp Hill,  PA  17011
Applicant Contact FRANK W JACKSON
Correspondent
Gi Supply
423n. 21st St.
Camp Hill,  PA  17011
Correspondent Contact FRANK W JACKSON
Regulation Number876.1500
Classification Product Code
MNK  
Date Received03/01/1993
Decision Date 10/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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