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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K954336
Device Name ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
Applicant
AUST & TAYLOR MEDICAL CORP.
7089 CROWNE OAK RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact STEPHAN NORSTED
Correspondent
AUST & TAYLOR MEDICAL CORP.
7089 CROWNE OAK RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact STEPHAN NORSTED
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/18/1995
Decision Date 11/13/1995
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
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