FDA 510(k)

DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G

K-Number: K941159 · 1994-05-19

Decision Date1994-05-19

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1994-05-19 under 510(k) number K941159. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G?

DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G is a medical device that received FDA 510(k) clearance on 1994-05-19. The listed applicant is International Technidyne Corp.. The 510(k) number is K941159.

When did DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G receive FDA 510(k) clearance?

DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G received FDA 510(k) clearance on 1994-05-19, under 510(k) number K941159.

Who is the listed applicant for DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G?

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

What is the FDA product code for DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G?

The FDA product code for DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G is JKA.

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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.