FDA 510(k)

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL

Numéro K : K153076 · 2016-06-16

Date de décision2016-06-16

Code produitGAT

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K153076. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL?

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K153076.

When did silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL receive FDA 510(k) clearance?

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL received FDA 510(k) clearance on 2016-06-16, under 510(k) number K153076.

Who is the listed applicant for silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL?

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

What is the FDA product code for silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL?

The FDA product code for silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL is GAT.

Essais cliniques associés

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Source officielle

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