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FDA 510(k)

BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS

K-Number: K930238 · 1993-08-16

ApplicantProlac, Inc.
Decision Date1993-08-16
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS is the device name listed in this FDA 510(k) record. The listed applicant is Prolac, Inc.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K930238. The device is classified under product code HFS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS?

BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is Prolac, Inc.. The 510(k) number is K930238.

When did BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS receive FDA 510(k) clearance?

BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS received FDA 510(k) clearance on 1993-08-16, under 510(k) number K930238.

Who is the listed applicant for BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS?

The FDA 510(k) record lists Prolac, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS?

The FDA product code for BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS is HFS.

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Related Devices (Code: HFS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944177BREAST SHELLO'Donnell, Byrne & WilliamsK944117AVENT NIPPLE SHIELDAvent America, Inc.K935341COMFORT PLUS BREAST SHELLSMarshall Baby ProductsK935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby ProductsK923577BREAST SHELLSMedela, Inc.K864176GENTLE FEELMali, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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