UROSURGE UROTHERM FLUID WARMING SYSTEM— 510(k) K965136

Name: FDA 510(k) clearance K965136
Creator: U.S. Food and Drug Administration
Published: 1998-10-16

Substantially Equivalent

Princeton Regulatory Assoc.

FDA 510(k) clearance K965136 for UROSURGE UROTHERM FLUID WARMING SYSTEM, Substantially Equivalent on 1998-10-16. Applicant: Princeton Regulatory Assoc.. Device class: 1.

Clearance details

Applicant: Princeton Regulatory Assoc.
Product code: Code LHC
Device class: Class 1
Regulation: 21 CFR 890.5950
Advisory panel: Physical Medicine
Date received: 1996-12-23
Decision date: 1998-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED2014-08-28

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