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510(k) Data Aggregation
K Number
K131617Device Name
COLONGLIDE(R) LUBRICANT
Manufacturer
PEDIATRIC PHARMACEUTICALS, INC.
Date Cleared
2013-10-03
(122 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Applicant Name (Manufacturer) :
PEDIATRIC PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Colonglide® Lubricant Is indicated for medical purposes for use to lubricate a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.
Device Description
Colonglide® Lubricant is a clear, colorless, non-sterile, odorless, water-based patient lubricant. The subject device is packaged for individual use in a 250 mL round plastic bottle sealed with a screw cap with a foil induction innerseal liner.
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