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FDA 510(k)

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS

K-Number: K063223 · 2008-01-23

ApplicantCooperSurgical, Inc.
Decision Date2008-01-23
Product CodeHDW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2008-01-23 under 510(k) number K063223. The device is classified under product code HDW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS?

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS is a medical device that received FDA 510(k) clearance on 2008-01-23. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K063223.

When did MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS receive FDA 510(k) clearance?

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS received FDA 510(k) clearance on 2008-01-23, under 510(k) number K063223.

Who is the listed applicant for MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS?

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

What is the FDA product code for MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS?

The FDA product code for MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS is HDW.

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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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