Cleared Traditional

UROSURGE ACUTRAINER

K962770 · Princeton Regulatory Assoc. · Gastroenterology & Urology
Aug 1996
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K962770 is an FDA 510(k) clearance for the UROSURGE ACUTRAINER, a Alarm, Conditioned Response Enuresis (Class II — Special Controls, product code KPN), submitted by Princeton Regulatory Assoc. (Princeton, US). The FDA issued a Cleared decision on August 1, 1996, 16 days after receiving the submission on July 16, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.2040.

Submission Details

510(k) Number K962770 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1996
Decision Date August 01, 1996
Days to Decision 16 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KPN — Alarm, Conditioned Response Enuresis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.2040

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