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FDA 510(k)

AVENT NIPPLE SHIELD

K-Number: K944117 · 1994-10-05

ApplicantAvent America, Inc.
Decision Date1994-10-05
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AVENT NIPPLE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Avent America, Inc.. It received FDA 510(k) clearance on 1994-10-05 under 510(k) number K944117. 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 AVENT NIPPLE SHIELD?

AVENT NIPPLE SHIELD is a medical device that received FDA 510(k) clearance on 1994-10-05. The listed applicant is Avent America, Inc.. The 510(k) number is K944117.

When did AVENT NIPPLE SHIELD receive FDA 510(k) clearance?

AVENT NIPPLE SHIELD received FDA 510(k) clearance on 1994-10-05, under 510(k) number K944117.

Who is the listed applicant for AVENT NIPPLE SHIELD?

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

What is the FDA product code for AVENT NIPPLE SHIELD?

The FDA product code for AVENT NIPPLE SHIELD is HFS.

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Other records listing Avent America, Inc. as applicant

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.

K052047ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101K051413ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100K952035NIPLETTE

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 & WilliamsK935341COMFORT PLUS BREAST SHELLSMarshall Baby ProductsK935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby ProductsK930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.K923577BREAST 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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