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FDA 510(k)

THE BIBICURE SYS BREAST TONER

K-Number: K843544 · 1985-01-25

ApplicantLes Entreprises Bibi, Inc.
Decision Date1985-01-25
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE BIBICURE SYS BREAST TONER is the device name listed in this FDA 510(k) record. The listed applicant is Les Entreprises Bibi, Inc.. It received FDA 510(k) clearance on 1985-01-25 under 510(k) number K843544. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BIBICURE SYS BREAST TONER?

THE BIBICURE SYS BREAST TONER is a medical device that received FDA 510(k) clearance on 1985-01-25. The listed applicant is Les Entreprises Bibi, Inc.. The 510(k) number is K843544.

When did THE BIBICURE SYS BREAST TONER receive FDA 510(k) clearance?

THE BIBICURE SYS BREAST TONER received FDA 510(k) clearance on 1985-01-25, under 510(k) number K843544.

Who is the listed applicant for THE BIBICURE SYS BREAST TONER?

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

What is the FDA product code for THE BIBICURE SYS BREAST TONER?

The FDA product code for THE BIBICURE SYS BREAST TONER is HGY.

Related Clinical Trials

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.

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Other records listing Les Entreprises Bibi, 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.

K843543THE BIBICURE SYS DERMEPIL NATURAL HAIR

Related Devices (Code: HGY)

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.

K101538HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK LimitedK032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK962828EVERT-ITGenesis Industries, 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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