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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K915816
Device Name BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY
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 Number874.4680
Classification Product Code
EOQ  
Date Received12/30/1991
Decision Date 03/27/1992
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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