CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE

Endoscopic Injection Needle, Gastroenterology-urology

CARBON MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Carbon Medical Technologies Injection Needle.

Pre-market Notification Details

Device IDK030451
510k NumberK030451
Device Name:CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
ContactRobert W Johnson
CorrespondentRobert W Johnson
CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-11
Decision Date2003-04-30
Summary:summary

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