COLONGLIDE(R) LUBRICANT— 510(k) K131617

Name: FDA 510(k) clearance K131617
Creator: U.S. Food and Drug Administration
Published: 2013-10-03

Substantially Equivalent

Pediatric Pharmaceuticals, Inc.

FDA 510(k) clearance K131617 for COLONGLIDE(R) LUBRICANT, Substantially Equivalent on 2013-10-03. Applicant: Pediatric Pharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant: Pediatric Pharmaceuticals, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2013-06-03
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holmdel, NJ, US

Download summary PDF View on FDA.gov ↗

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