FDA 510(k)

Dr J Spinal and Epidural Needles

Numéro K : K183316 · 2019-08-12

Date de décision2019-08-12

Code produitBSP

Comité consultatifAN

DécisionSubstantially Equivalent

Résumé du dispositif

Dr J Spinal and Epidural Needles is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Japan Co., Ltd.. It received FDA 510(k) clearance on 2019-08-12 under 510(k) number K183316. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Dr J Spinal and Epidural Needles?

Dr J Spinal and Epidural Needles is a medical device that received FDA 510(k) clearance on 2019-08-12. The listed applicant is Dr. Japan Co., Ltd.. The 510(k) number is K183316.

When did Dr J Spinal and Epidural Needles receive FDA 510(k) clearance?

Dr J Spinal and Epidural Needles received FDA 510(k) clearance on 2019-08-12, under 510(k) number K183316.

Who is the listed applicant for Dr J Spinal and Epidural Needles?

The FDA 510(k) record lists Dr. Japan Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dr J Spinal and Epidural Needles?

The FDA product code for Dr J Spinal and Epidural Needles is BSP.

Essais cliniques associés

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Dispositifs connexes (Code : BSP)

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Source officielle

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