BABY TEETHER, MODEL 20104

• K Number: K014023
• Device Name: BABY TEETHER, MODEL 20104
• Manufacturer: ANGELINA TRADING, INC.
• Date Cleared: 2002-08-02 ( 239 days)
• Product Code: KKO
• Regulation Number: 872.5550
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

FOR BABY TO CHEW AND PLAY WITH.

Device Description

BABY TEETHER

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a "Baby Teether" device. It confirms the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed.

The document discusses regulatory compliance, labeling, and good manufacturing practices, but it does not detail any specific performance acceptance criteria or a study that evaluated the device's performance against such criteria.

Regulation Number and Section

§ 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.