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FDA 510(k)

WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM

K-Number: K964848 · 1997-01-16

ApplicantMarlow Surgical Technologies, Inc.
Decision Date1997-01-16
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM is the device name listed in this FDA 510(k) record. The listed applicant is Marlow Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1997-01-16 under 510(k) number K964848. 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 WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM?

WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM is a medical device that received FDA 510(k) clearance on 1997-01-16. The listed applicant is Marlow Surgical Technologies, Inc.. The 510(k) number is K964848.

When did WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM receive FDA 510(k) clearance?

WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM received FDA 510(k) clearance on 1997-01-16, under 510(k) number K964848.

Who is the listed applicant for WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM?

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

What is the FDA product code for WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM?

The FDA product code for WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM is MFD.

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Other records listing Marlow Surgical Technologies, 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.

K944563FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS

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

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