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FDA 510(k)

KRONNER MANIPUJECTOR

K-Number: K904473 · 1990-12-14

ApplicantUnimar, Inc.
Decision Date1990-12-14
Product CodeHES
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KRONNER MANIPUJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1990-12-14 under 510(k) number K904473. The device is classified under product code HES. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KRONNER MANIPUJECTOR?

KRONNER MANIPUJECTOR is a medical device that received FDA 510(k) clearance on 1990-12-14. The listed applicant is Unimar, Inc.. The 510(k) number is K904473.

When did KRONNER MANIPUJECTOR receive FDA 510(k) clearance?

KRONNER MANIPUJECTOR received FDA 510(k) clearance on 1990-12-14, under 510(k) number K904473.

Who is the listed applicant for KRONNER MANIPUJECTOR?

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

What is the FDA product code for KRONNER MANIPUJECTOR?

The FDA product code for KRONNER MANIPUJECTOR is HES.

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Other records listing Unimar, 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.

K932432KRONNER REINFORCING STYLETTEK920803HSG TRAYK910317UNI-SEM(TM)K895659HUI MINI-FLEXK895403ASPIRETTE ENDOCERVICAL ASPIRATORK894264KDF-2.3

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Related Devices (Code: HES)

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.

K000340HYSTALOG HSG CATHETERRocket Medical PlcK903209MAXI-FLOW INSUFFLATOR TUBING SET W/FILTERAdler Instrument Co.K903208MAXI-FLOW INSUFFLATOR TUBING SETAdler Instrument Co.K901413CORE DISPOSABLE INSUFFLATION TUBINGCore Dynamics, Inc.K891290SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERCook Ob/GynK890869BARD HYSTEROSALPINGOGRAPHY CATHETERSC.R. Bard, 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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