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FDA 510(k)

#556 DISPOSABLE UMBILICAL CORD CLAMP (2)

K-Number: K894646 · 1989-09-05

ApplicantAlpha Unlimited, Inc.
Decision Date1989-09-05
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

#556 DISPOSABLE UMBILICAL CORD CLAMP (2) is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Unlimited, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894646. 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 #556 DISPOSABLE UMBILICAL CORD CLAMP (2)?

#556 DISPOSABLE UMBILICAL CORD CLAMP (2) is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Alpha Unlimited, Inc.. The 510(k) number is K894646.

When did #556 DISPOSABLE UMBILICAL CORD CLAMP (2) receive FDA 510(k) clearance?

#556 DISPOSABLE UMBILICAL CORD CLAMP (2) received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894646.

Who is the listed applicant for #556 DISPOSABLE UMBILICAL CORD CLAMP (2)?

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

What is the FDA product code for #556 DISPOSABLE UMBILICAL CORD CLAMP (2)?

The FDA product code for #556 DISPOSABLE UMBILICAL CORD CLAMP (2) is HFW.

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Other records listing Alpha Unlimited, 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.

K893429ALPHA CONDORK893428ALPHA SHOPPERK893248ALPHA MALLARDK853766ALPHA SUPER KARTK841921ALPHA PLUS 1K841911ALPHA PUSH KART

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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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