FDA 510(k)

Cranial Drill Bits and Accessories

Numéro K : K170442 · 2017-09-07

DemandeurAd-Tech Medical Instrument Corporation

Date de décision2017-09-07

Code produitHBE

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Cranial Drill Bits and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170442. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Cranial Drill Bits and Accessories?

Cranial Drill Bits and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K170442.

When did Cranial Drill Bits and Accessories receive FDA 510(k) clearance?

Cranial Drill Bits and Accessories received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170442.

Who is the listed applicant for Cranial Drill Bits and Accessories?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial Drill Bits and Accessories?

The FDA product code for Cranial Drill Bits and Accessories is HBE.

Essais cliniques associés

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Autres dossiers indiquant Ad-Tech Medical Instrument Corporation en tant que demandeur

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Dispositifs connexes (Code : HBE)

Source officielle

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