SCOPESCRUBBER(TM)

Nasopharyngoscope (flexible Or Rigid)

HEALTHTEK MICROSURGICAL, INC.

The following data is part of a premarket notification filed by Healthtek Microsurgical, Inc. with the FDA for Scopescrubber(tm).

Pre-market Notification Details

Device IDK902683
510k NumberK902683
Device Name:SCOPESCRUBBER(TM)
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant HEALTHTEK MICROSURGICAL, INC. JEFF MANNI, SUITE 400 6 NEW ENGLAND EXECUTIVE PARK Burlington,  MA  01803
ContactJm Associates
CorrespondentJm Associates
HEALTHTEK MICROSURGICAL, INC. JEFF MANNI, SUITE 400 6 NEW ENGLAND EXECUTIVE PARK Burlington,  MA  01803
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-19
Decision Date1990-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00681490046039 K902683 000
20613994661948 K902683 000
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20613994661962 K902683 000
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20613994662020 K902683 000
20613994662013 K902683 000
20613994662006 K902683 000
20613994661993 K902683 000
00763000008147 K902683 000

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