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FDA 510(k)

LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9

K-Number: K871304 · 1987-06-11

ApplicantAnsell, Inc.
Decision Date1987-06-11
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871304. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9?

LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Ansell, Inc.. The 510(k) number is K871304.

When did LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 receive FDA 510(k) clearance?

LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871304.

Who is the listed applicant for LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9?

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

What is the FDA product code for LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9?

The FDA product code for LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9 is HIS.

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Other records listing Ansell, Inc. as applicant

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Related Devices (Code: HIS)

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Official Source

View on FDA Database →

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

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