R&D PART NOS. 5490, 5541, 5358, 5497— 510(k) K945870

Name: FDA 510(k) clearance K945870
Creator: U.S. Food and Drug Administration
Published: 1995-03-23

Substantially Equivalent

R & D Batteries, Inc.

FDA 510(k) clearance K945870 for R&D PART NOS. 5490, 5541, 5358, 5497, Substantially Equivalent on 1995-03-23. Applicant: R & D Batteries, Inc.. Device class: 1.

Clearance details

Applicant: R & D Batteries, Inc.
Product code: Code FCO
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-12-01
Decision date: 1995-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, US

Download summary PDF View on FDA.gov ↗

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