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FDA 510(k)

BREAST SHELLS

K-Number: K923577 · 1993-01-22

ApplicantMedela, Inc.
Decision Date1993-01-22
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BREAST SHELLS is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1993-01-22 under 510(k) number K923577. 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 SHELLS?

BREAST SHELLS is a medical device that received FDA 510(k) clearance on 1993-01-22. The listed applicant is Medela, Inc.. The 510(k) number is K923577.

When did BREAST SHELLS receive FDA 510(k) clearance?

BREAST SHELLS received FDA 510(k) clearance on 1993-01-22, under 510(k) number K923577.

Who is the listed applicant for BREAST SHELLS?

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

What is the FDA product code for BREAST SHELLS?

The FDA product code for BREAST SHELLS is HFS.

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Other records listing Medela, 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.

K161811Medela Low Dose Enteral SyringeK161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailK031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMPK020518MEDELA SYMPHONY BREAST PUMP, MODEL 024K984589PHOTOTHERAPY LAMPK983552BASIC, MEDIAN, DOMINANT, AND VARIO

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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 ProductsK930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.K864176GENTLE FEELMali, Inc.

Official Source

View on FDA Database →

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

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