FDA 510(k)

GEL-TAC(R)

K-Number: K895009 · 1989-12-13

Decision Date1989-12-13

Product CodeLDD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

GEL-TAC(R) is the device name listed in this FDA 510(k) record. The listed applicant is Padeco, Inc.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K895009. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEL-TAC(R)?

GEL-TAC(R) is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Padeco, Inc.. The 510(k) number is K895009.

When did GEL-TAC(R) receive FDA 510(k) clearance?

GEL-TAC(R) received FDA 510(k) clearance on 1989-12-13, under 510(k) number K895009.

Who is the listed applicant for GEL-TAC(R)?

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

What is the FDA product code for GEL-TAC(R)?

The FDA product code for GEL-TAC(R) is LDD.

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Official Source

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