COLONGLIDE LUBRICANT— 510(k) K141028

Name: FDA 510(k) clearance K141028
Creator: U.S. Food and Drug Administration
Published: 2014-07-24

Substantially Equivalent

Pediatric Pharmaceuticals, Inc.

FDA 510(k) clearance K141028 for COLONGLIDE LUBRICANT, Substantially Equivalent on 2014-07-24. 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: 2014-04-22
Decision date: 2014-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Holmdel, NJ, US

Download summary PDF View on FDA.gov ↗

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