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FDA 510(k)

UNI-SEM(TM)

K-Number: K910317 · 1991-05-01

ApplicantUnimar, Inc.
Decision Date1991-05-01
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UNI-SEM(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Unimar, Inc.. It received FDA 510(k) clearance on 1991-05-01 under 510(k) number K910317. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-SEM(TM)?

UNI-SEM(TM) is a medical device that received FDA 510(k) clearance on 1991-05-01. The listed applicant is Unimar, Inc.. The 510(k) number is K910317.

When did UNI-SEM(TM) receive FDA 510(k) clearance?

UNI-SEM(TM) received FDA 510(k) clearance on 1991-05-01, under 510(k) number K910317.

Who is the listed applicant for UNI-SEM(TM)?

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 UNI-SEM(TM)?

The FDA product code for UNI-SEM(TM) is MFD.

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 TRAYK904473KRONNER MANIPUJECTORK895659HUI MINI-FLEXK895403ASPIRETTE ENDOCERVICAL ASPIRATORK894264KDF-2.3

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Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK012935THECURVE, ITEM 507Select Medical Systems, Inc.K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc

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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