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FDA 510(k)

KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR

K-Number: K951140 · 1995-05-25

ApplicantBalagan Medical, Inc.
Decision Date1995-05-25
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Balagan Medical, Inc.. It received FDA 510(k) clearance on 1995-05-25 under 510(k) number K951140. The device is classified under product code HFW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR?

KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Balagan Medical, Inc.. The 510(k) number is K951140.

When did KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR receive FDA 510(k) clearance?

KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR received FDA 510(k) clearance on 1995-05-25, under 510(k) number K951140.

Who is the listed applicant for KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR?

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

What is the FDA product code for KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR?

The FDA product code for KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR is HFW.

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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Related Devices (Code: HFW)

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.

K041332JOEY CLAMP OPENING TOOLMaternus, Inc.K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BDynarex Corp.K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, 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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