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FDA 510(k)

LIFESTYLES XTRA PLEASURE

K-Number: K983518 · 1999-07-06

ApplicantAnsell, Inc.
Decision Date1999-07-06
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIFESTYLES XTRA PLEASURE is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1999-07-06 under 510(k) number K983518. 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 XTRA PLEASURE?

LIFESTYLES XTRA PLEASURE is a medical device that received FDA 510(k) clearance on 1999-07-06. The listed applicant is Ansell, Inc.. The 510(k) number is K983518.

When did LIFESTYLES XTRA PLEASURE receive FDA 510(k) clearance?

LIFESTYLES XTRA PLEASURE received FDA 510(k) clearance on 1999-07-06, under 510(k) number K983518.

Who is the listed applicant for LIFESTYLES XTRA PLEASURE?

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 XTRA PLEASURE?

The FDA product code for LIFESTYLES XTRA PLEASURE is HIS.

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.

Other records listing Ansell, 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.

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Related Devices (Code: HIS)

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.

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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