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K Number
K981549
Device Name
LACTATION TECHNIQUES MODEL B
Manufacturer
LACTATION TECHNIQUES, INC.
Date Cleared
1999-05-24

(389 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Lactation Techniques TM Model B auto cycling breast pump is to aid nursing mothers at home with the extraction of breast milk in the absence of the nursing child due to illness or other situations causing temporary separation.

Device Description

Lactation Techniques™Model B Powered Breast Pump

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a breast pump, specifically the Lactation Techniques™ Model B Powered Breast Pump. It does not contain any information regarding acceptance criteria, study details, or device performance data.

Therefore, I cannot provide the requested information. The letter only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).