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FDA 510(k)

UNICARE BREAST SHELLS

K-Number: K861608 · 1986-07-15

ApplicantUnicare Medical Products, Inc.
Decision Date1986-07-15
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNICARE BREAST SHELLS is the device name listed in this FDA 510(k) record. The listed applicant is Unicare Medical Products, Inc.. It received FDA 510(k) clearance on 1986-07-15 under 510(k) number K861608. 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 UNICARE BREAST SHELLS?

UNICARE BREAST SHELLS is a medical device that received FDA 510(k) clearance on 1986-07-15. The listed applicant is Unicare Medical Products, Inc.. The 510(k) number is K861608.

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

UNICARE BREAST SHELLS received FDA 510(k) clearance on 1986-07-15, under 510(k) number K861608.

Who is the listed applicant for UNICARE BREAST SHELLS?

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

What is the FDA product code for UNICARE BREAST SHELLS?

The FDA product code for UNICARE BREAST SHELLS 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.

K944117AVENT NIPPLE SHIELDAvent America, Inc.K944177BREAST SHELLO'Donnell, Byrne & WilliamsK935341COMFORT PLUS BREAST SHELLSMarshall Baby ProductsK935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby ProductsK930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.K923577BREAST SHELLSMedela, 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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