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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 K945081
Device Name TRANSTYMPANIC ENDOSCOPE
Applicant
Endooptiks, Inc.
39 Sycamore Ave.
Little Silver,  NJ  07739
Applicant Contact JIM OHNECK
Correspondent
Endooptiks, Inc.
39 Sycamore Ave.
Little Silver,  NJ  07739
Correspondent Contact JIM OHNECK
Regulation Number874.4760
Classification Product Code
EOB  
Date Received10/17/1994
Decision Date 03/06/1995
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
Predetermined Change
Control Plan Authorized		 No
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