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FDA 510(k)

TACTYLON CONDOM

K-Number: K971590 · 1997-10-07

ApplicantSensicon Corp.
Decision Date1997-10-07
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TACTYLON CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Sensicon Corp.. It received FDA 510(k) clearance on 1997-10-07 under 510(k) number K971590. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TACTYLON CONDOM?

TACTYLON CONDOM is a medical device that received FDA 510(k) clearance on 1997-10-07. The listed applicant is Sensicon Corp.. The 510(k) number is K971590.

When did TACTYLON CONDOM receive FDA 510(k) clearance?

TACTYLON CONDOM received FDA 510(k) clearance on 1997-10-07, under 510(k) number K971590.

Who is the listed applicant for TACTYLON CONDOM?

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

What is the FDA product code for TACTYLON CONDOM?

The FDA product code for TACTYLON CONDOM is MOL.

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 Sensicon Corp. 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.

K974121LUBRICATED BAGGY TACTYLON CONDOM

Related Devices (Code: MOL)

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.

K252158Sagami Original 002 Polyurethane Male CondomMayer LaboratoriesK243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLCK240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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