BILIARY BALLOON DILATOR

Stents, Drains And Dilators For The Biliary Ducts

TELEMED SYSTEMS, INC.

The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Biliary Balloon Dilator.

Pre-market Notification Details

Device IDK901432
510k NumberK901432
Device Name:BILIARY BALLOON DILATOR
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson,  MA  01749
ContactJohn A Chaves
CorrespondentJohn A Chaves
TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson,  MA  01749
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-26
Decision Date1990-06-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813353010103 K901432 000
00813353010097 K901432 000
00813353010080 K901432 000

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