FDA 510(k)

SYLK PERSONAL LUBRICANT

N.º K: K152646 · 2016-03-11

SolicitanteToro Management, LLC Dba Sylk

Fecha de decisión2016-03-11

Código de productoNUC

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

SYLK PERSONAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Toro Management, LLC Dba Sylk. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K152646. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SYLK PERSONAL LUBRICANT?

SYLK PERSONAL LUBRICANT is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Toro Management, LLC Dba Sylk. The 510(k) number is K152646.

When did SYLK PERSONAL LUBRICANT receive FDA 510(k) clearance?

SYLK PERSONAL LUBRICANT received FDA 510(k) clearance on 2016-03-11, under 510(k) number K152646.

Who is the listed applicant for SYLK PERSONAL LUBRICANT?

The FDA 510(k) record lists Toro Management, LLC Dba Sylk as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYLK PERSONAL LUBRICANT?

The FDA product code for SYLK PERSONAL LUBRICANT is NUC.

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Fuente oficial

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