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FDA 510(k)

DYNAPHOR(TM) TWO

K-Number: K935868 · 1995-03-15

ApplicantMaxxim Medical
Decision Date1995-03-15
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNAPHOR(TM) TWO is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 1995-03-15 under 510(k) number K935868. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAPHOR(TM) TWO?

DYNAPHOR(TM) TWO is a medical device that received FDA 510(k) clearance on 1995-03-15. The listed applicant is Maxxim Medical. The 510(k) number is K935868.

When did DYNAPHOR(TM) TWO receive FDA 510(k) clearance?

DYNAPHOR(TM) TWO received FDA 510(k) clearance on 1995-03-15, under 510(k) number K935868.

Who is the listed applicant for DYNAPHOR(TM) TWO?

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

What is the FDA product code for DYNAPHOR(TM) TWO?

The FDA product code for DYNAPHOR(TM) TWO is EGJ.

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Related Devices (Code: EGJ)

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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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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