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FDA 510(k)

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

K-Number: K991047 · 1999-06-18

ApplicantHardcover Products, Inc.
Decision Date1999-06-18
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) is the device name listed in this FDA 510(k) record. The listed applicant is Hardcover Products, Inc.. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K991047. 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 HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)?

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Hardcover Products, Inc.. The 510(k) number is K991047.

When did HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) receive FDA 510(k) clearance?

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991047.

Who is the listed applicant for HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)?

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

What is the FDA product code for HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)?

The FDA product code for HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) is LTZ.

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 Hardcover Products, 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.

K990925MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

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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