FOREIGN BODY PROTECTOR

Endoscopic Access Overtube, Gastroenterology-urology

JAYCO PHARMACEUTICALS

The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Foreign Body Protector.

Pre-market Notification Details

Device IDK841258
510k NumberK841258
Device Name:FOREIGN BODY PROTECTOR
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant JAYCO PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-26
Decision Date1984-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10350770928101 K841258 000

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