FDA 510(k)

ACE BOND SE

K-Number: K063780 · 2007-01-19

Decision Date2007-01-19

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ACE BOND SE is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2007-01-19 under 510(k) number K063780. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE BOND SE?

ACE BOND SE is a medical device that received FDA 510(k) clearance on 2007-01-19. The listed applicant is Bisco, Inc.. The 510(k) number is K063780.

When did ACE BOND SE receive FDA 510(k) clearance?

ACE BOND SE received FDA 510(k) clearance on 2007-01-19, under 510(k) number K063780.

Who is the listed applicant for ACE BOND SE?

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

What is the FDA product code for ACE BOND SE?

The FDA product code for ACE BOND SE is KLE.

Other records listing Bisco, Inc. as applicant

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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.