VANCE CYSTOSCOPIC

Endoscopic Injection Needle, Gastroenterology-urology

VANCE PRODUCTS, INC.

The following data is part of a premarket notification filed by Vance Products, Inc. with the FDA for Vance Cystoscopic.

Pre-market Notification Details

Device IDK812057
510k NumberK812057
Device Name:VANCE CYSTOSCOPIC
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant VANCE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-21
Decision Date1981-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002152960 K812057 000
00827002152762 K812057 000
00827002142206 K812057 000
00827002162693 K812057 000
00827002158641 K812057 000

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