NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO— 510(k) K925161

Name: FDA 510(k) clearance K925161
Creator: U.S. Food and Drug Administration
Published: 1993-07-21

Substantially Equivalent

North American Sterilization & Packaging Co.

FDA 510(k) clearance K925161 for NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO, Substantially Equivalent on 1993-07-21. Applicant: North American Sterilization & Packaging Co.. Device class: 2.

Clearance details

Applicant: North American Sterilization & Packaging Co.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1992-10-13
Decision date: 1993-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparta, NJ, US

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