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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 K882744
Device Name EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
Applicant
EFFNER, INC.
POST OFFICE BOX 191
PORT WASHINGTON,  NY  11050
Applicant Contact INGE HAMER
Correspondent
EFFNER, INC.
POST OFFICE BOX 191
PORT WASHINGTON,  NY  11050
Correspondent Contact INGE HAMER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/01/1988
Decision Date 08/10/1988
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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