TENDERFOOT(R), MODIFICATION

Device, Bleeding Time

INTERNATIONAL TECHNIDYNE CORP.

The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Tenderfoot(r), Modification.

Pre-market Notification Details

Device IDK911997
510k NumberK911997
Device Name:TENDERFOOT(R), MODIFICATION
ClassificationDevice, Bleeding Time
Applicant INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison,  NJ  08820
ContactLes Heimann
CorrespondentLes Heimann
INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison,  NJ  08820
Product CodeJCA  
CFR Regulation Number864.6100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-22
Decision Date1991-07-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20711234312022 K911997 000
20711234303082 K911997 000
20711234302160 K911997 000
20711234302153 K911997 000
20711234302139 K911997 000

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