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FDA 510(k)

MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE

K-Number: K934011 · 1994-05-04

ApplicantNeward Enterprises, Inc.
Decision Date1994-05-04
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE is the device name listed in this FDA 510(k) record. The listed applicant is Neward Enterprises, Inc.. It received FDA 510(k) clearance on 1994-05-04 under 510(k) number K934011. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE?

MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Neward Enterprises, Inc.. The 510(k) number is K934011.

When did MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE receive FDA 510(k) clearance?

MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE received FDA 510(k) clearance on 1994-05-04, under 510(k) number K934011.

Who is the listed applicant for MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE?

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

What is the FDA product code for MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE?

The FDA product code for MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE is HDB.

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Other records listing Neward Enterprises, 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.

K960549MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLEK943938MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLEK925572MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATEK913324MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KITK910815CR SPIRAL ELECTRODEK890307MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE

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Related Devices (Code: HDB)

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.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AGK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products

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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