THREADED FIXATION PIN

Pin, Fixation, Threaded

SGARLATO LABORATORIES, INC.

The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Threaded Fixation Pin.

Pre-market Notification Details

Device IDK982931
510k NumberK982931
Device Name:THREADED FIXATION PIN
ClassificationPin, Fixation, Threaded
Applicant SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos,  CA  95030
ContactThomas Sgarlato
CorrespondentThomas Sgarlato
SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos,  CA  95030
Product CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-20
Decision Date1998-10-21
Summary:summary

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