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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 K902683
Device Name SCOPESCRUBBER(TM)
Applicant
HEALTHTEK MICROSURGICAL, INC.
JEFF MANNI, SUITE 400
6 NEW ENGLAND EXECUTIVE PARK
BURLINGTON,  MA  01803
Applicant Contact JM ASSOCIATES
Correspondent
HEALTHTEK MICROSURGICAL, INC.
JEFF MANNI, SUITE 400
6 NEW ENGLAND EXECUTIVE PARK
BURLINGTON,  MA  01803
Correspondent Contact JM ASSOCIATES
Regulation Number874.4760
Classification Product Code
EOB  
Date Received06/19/1990
Decision Date 10/31/1990
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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