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FDA 510(k)

ORTHO ALL-FLEX DIAPHRAGM

K-Number: K080040 · 2008-08-25

ApplicantJohnson & Johnson Produtos Profissionais Ltda.
Decision Date2008-08-25
Product CodeHDW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORTHO ALL-FLEX DIAPHRAGM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Produtos Profissionais Ltda.. It received FDA 510(k) clearance on 2008-08-25 under 510(k) number K080040. 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 ORTHO ALL-FLEX DIAPHRAGM?

ORTHO ALL-FLEX DIAPHRAGM is a medical device that received FDA 510(k) clearance on 2008-08-25. The listed applicant is Johnson & Johnson Produtos Profissionais Ltda.. The 510(k) number is K080040.

When did ORTHO ALL-FLEX DIAPHRAGM receive FDA 510(k) clearance?

ORTHO ALL-FLEX DIAPHRAGM received FDA 510(k) clearance on 2008-08-25, under 510(k) number K080040.

Who is the listed applicant for ORTHO ALL-FLEX DIAPHRAGM?

The FDA 510(k) record lists Johnson & Johnson Produtos Profissionais Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO ALL-FLEX DIAPHRAGM?

The FDA product code for ORTHO ALL-FLEX DIAPHRAGM is HDW.

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Related Devices (Code: HDW)

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.

K063223MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMSCooperSurgical, Inc.K800162ONCE TMG.D. Searle and Co.

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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