SURGICOT STEAM TEST PACK

Indicator, Biological Sterilization Process

SURGICOT, INC.

The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Surgicot Steam Test Pack.

Pre-market Notification Details

Device IDK854902
510k NumberK854902
Device Name:SURGICOT STEAM TEST PACK
ClassificationIndicator, Biological Sterilization Process
Applicant SURGICOT, INC. 55 KENNEDY DR. Smithtown,  NY  11787
ContactJames Brown
CorrespondentJames Brown
SURGICOT, INC. 55 KENNEDY DR. Smithtown,  NY  11787
Product CodeFRC  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-09
Decision Date1986-05-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00724995220334 K854902 000
00724995220327 K854902 000
00724995220310 K854902 000
00724995220303 K854902 000

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