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FDA 510(k)

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)

K-Number: K961993 · 1996-07-03

ApplicantDevon Industries, Inc.
Decision Date1996-07-03
Product CodeMLS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Devon Industries, Inc.. It received FDA 510(k) clearance on 1996-07-03 under 510(k) number K961993. The device is classified under product code MLS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)?

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) is a medical device that received FDA 510(k) clearance on 1996-07-03. The listed applicant is Devon Industries, Inc.. The 510(k) number is K961993.

When did BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) receive FDA 510(k) clearance?

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) received FDA 510(k) clearance on 1996-07-03, under 510(k) number K961993.

Who is the listed applicant for BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)?

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

What is the FDA product code for BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)?

The FDA product code for BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) is MLS.

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 Devon Industries, 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.

K954015ABG POINT LOK NEEDLE PROTECTION DEVICEK946289DEVONS POINT LOK NEEDLE PROTECTION DEVICEK943892POINT OF USE SHARPS A GATORK944114PHLEBOTOMY UNIT SHARPS A GATORK945197THE SHARPS COLLECTION AND DISPOSAL SYSTEMK945485ABG NEEDLE PROTECTION

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Related Devices (Code: MLS)

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.

K960243CPR C-SECTION DELIVERY PACKCustom Pack ReliabilityK940518C-SECTION TRAYCush Medical ProductsK932216C-SECTION, LABOR & DELIVERY TRAYS (PACKS)Associated Medical Products Co.K936120LABOR AND DELIVERY TRAYCush Medical ProductsK931722CARAPACE LABOR AND DELIVERY SETSCarapace, 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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