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FDA 510(k)

K-SPRAY, MODEL 085-2715

K-Number: K062418 · 2006-10-19

ApplicantScican
Decision Date2006-10-19
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K-SPRAY, MODEL 085-2715 is the device name listed in this FDA 510(k) record. The listed applicant is Scican. It received FDA 510(k) clearance on 2006-10-19 under 510(k) number K062418. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SPRAY, MODEL 085-2715?

K-SPRAY, MODEL 085-2715 is a medical device that received FDA 510(k) clearance on 2006-10-19. The listed applicant is Scican. The 510(k) number is K062418.

When did K-SPRAY, MODEL 085-2715 receive FDA 510(k) clearance?

K-SPRAY, MODEL 085-2715 received FDA 510(k) clearance on 2006-10-19, under 510(k) number K062418.

Who is the listed applicant for K-SPRAY, MODEL 085-2715?

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

What is the FDA product code for K-SPRAY, MODEL 085-2715?

The FDA product code for K-SPRAY, MODEL 085-2715 is EFB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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