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K Number
K091198
Device Name
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
Manufacturer
ALLIED HILL ENTERPRISES, LTD.
Date Cleared
2009-12-07

(227 days)

Product Code
KKO
Regulation Number
872.5550
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.

Device Description

Water Filled Teether

AI/ML Overview

I am sorry, but this document contains no information about acceptance criteria or study results for a medical device. The document is a 510(k) premarket notification letter from the FDA to Allied Hill Enterprises, Limited, regarding a "Water Filled Teether." It primarily discusses the substantial equivalence determination for the device and regulatory requirements.

Therefore, I cannot provide the requested information.

§ 872.5550 Teething ring.

(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.