DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9— 510(k) K920693

Name: FDA 510(k) clearance K920693
Creator: U.S. Food and Drug Administration
Published: 1992-09-21

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K920693 for DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9, Substantially Equivalent on 1992-09-21. Applicant: National Medical Care, Medical Products Div., Inc.. Device class: 2.

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-14
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

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