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FDA 510(k)

SPERMICIDAL LUBRICATED CONDOM

K-Number: K931220 · 1996-05-22

ApplicantMonsys USA, Inc.
Decision Date1996-05-22
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SPERMICIDAL LUBRICATED CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Monsys USA, Inc.. It received FDA 510(k) clearance on 1996-05-22 under 510(k) number K931220. The device is classified under product code LTZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPERMICIDAL LUBRICATED CONDOM?

SPERMICIDAL LUBRICATED CONDOM is a medical device that received FDA 510(k) clearance on 1996-05-22. The listed applicant is Monsys USA, Inc.. The 510(k) number is K931220.

When did SPERMICIDAL LUBRICATED CONDOM receive FDA 510(k) clearance?

SPERMICIDAL LUBRICATED CONDOM received FDA 510(k) clearance on 1996-05-22, under 510(k) number K931220.

Who is the listed applicant for SPERMICIDAL LUBRICATED CONDOM?

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

What is the FDA product code for SPERMICIDAL LUBRICATED CONDOM?

The FDA product code for SPERMICIDAL LUBRICATED CONDOM is LTZ.

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Related Devices (Code: LTZ)

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.

K033163CAUTION CONDOMSRichard Van Haussen America, Inc.K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMMedtech Products , Ltd.K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. BhdK003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMPleasure Latex Products Sdn. Bhd.

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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