NASAL DORSAL SERIES

Prosthesis, Nose, Internal

SURGICAL TECHNOLOGY LABORATORIES, INC.

The following data is part of a premarket notification filed by Surgical Technology Laboratories, Inc. with the FDA for Nasal Dorsal Series.

Pre-market Notification Details

Device IDK983755
510k NumberK983755
Device Name:NASAL DORSAL SERIES
ClassificationProsthesis, Nose, Internal
Applicant SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland,  OH  44103
ContactRichard T Nock
CorrespondentRichard T Nock
SURGICAL TECHNOLOGY LABORATORIES, INC. 1588 EAST 40TH ST. Cleveland,  OH  44103
Product CodeFZE  
CFR Regulation Number878.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-22
Decision Date1998-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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