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FDA 510(k)

LATEX CONDOMS (NATURAL COLOUR)

K-Number: K974326 · 1998-02-09

ApplicantReddy Medtech Health Products , Ltd.
Decision Date1998-02-09
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LATEX CONDOMS (NATURAL COLOUR) is the device name listed in this FDA 510(k) record. The listed applicant is Reddy Medtech Health Products , Ltd.. It received FDA 510(k) clearance on 1998-02-09 under 510(k) number K974326. 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 LATEX CONDOMS (NATURAL COLOUR)?

LATEX CONDOMS (NATURAL COLOUR) is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is Reddy Medtech Health Products , Ltd.. The 510(k) number is K974326.

When did LATEX CONDOMS (NATURAL COLOUR) receive FDA 510(k) clearance?

LATEX CONDOMS (NATURAL COLOUR) received FDA 510(k) clearance on 1998-02-09, under 510(k) number K974326.

Who is the listed applicant for LATEX CONDOMS (NATURAL COLOUR)?

The FDA 510(k) record lists Reddy Medtech Health Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX CONDOMS (NATURAL COLOUR)?

The FDA product code for LATEX CONDOMS (NATURAL COLOUR) 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 Reddy Medtech Health Products , Ltd. 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.

K980019HTL MALE CONDOMK974323LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANTK974324LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT

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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