FDA 510(k)

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed

Numéro K : K161737 · 2017-03-02

Date de décision2017-03-02

Code produitNEW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed is the device name listed in this FDA 510(k) record. The listed applicant is Myco Medical. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K161737. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed?

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Myco Medical. The 510(k) number is K161737.

When did RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed receive FDA 510(k) clearance?

RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed received FDA 510(k) clearance on 2017-03-02, under 510(k) number K161737.

Who is the listed applicant for RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed?

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

What is the FDA product code for RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed?

The FDA product code for RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed is NEW.

Essais cliniques associés

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Source officielle

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