BIOSOICS SPHINCTER TRAINING SYSTEM— 510(k) K862683

Name: FDA 510(k) clearance K862683
Creator: U.S. Food and Drug Administration
Published: 1986-11-12

Substantially Equivalent

Biosonics, Inc.

FDA 510(k) clearance K862683 for BIOSOICS SPHINCTER TRAINING SYSTEM, Substantially Equivalent on 1986-11-12. Applicant: Biosonics, Inc.. Device class: 2.

Clearance details

Applicant: Biosonics, Inc.
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-15
Decision date: 1986-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

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