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FDA 510(k)

WOMEN AND INFANT'S DELIVERY PACK

K-Number: K912869 · 1991-12-04

ApplicantWelcon, Inc.
Decision Date1991-12-04
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WOMEN AND INFANT'S DELIVERY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Welcon, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K912869. 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 WOMEN AND INFANT'S DELIVERY PACK?

WOMEN AND INFANT'S DELIVERY PACK is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Welcon, Inc.. The 510(k) number is K912869.

When did WOMEN AND INFANT'S DELIVERY PACK receive FDA 510(k) clearance?

WOMEN AND INFANT'S DELIVERY PACK received FDA 510(k) clearance on 1991-12-04, under 510(k) number K912869.

Who is the listed applicant for WOMEN AND INFANT'S DELIVERY PACK?

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

What is the FDA product code for WOMEN AND INFANT'S DELIVERY PACK?

The FDA product code for WOMEN AND INFANT'S DELIVERY PACK is HFW.

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Other records listing Welcon, 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.

K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONK973734STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONK971764WELCON HUE-VU URINARY DRAINAGE BAGK904158ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAYK894397WELCON LIGHT HANDLEK830359STERILE CATHERIZATION PROCEDURE TRAYS

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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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