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FDA 510(k)

SMARTBOND

K-Number: K981036 · 1999-04-05

ApplicantGac Intl., Inc.
Decision Date1999-04-05
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTBOND is the device name listed in this FDA 510(k) record. The listed applicant is Gac Intl., Inc.. It received FDA 510(k) clearance on 1999-04-05 under 510(k) number K981036. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTBOND?

SMARTBOND is a medical device that received FDA 510(k) clearance on 1999-04-05. The listed applicant is Gac Intl., Inc.. The 510(k) number is K981036.

When did SMARTBOND receive FDA 510(k) clearance?

SMARTBOND received FDA 510(k) clearance on 1999-04-05, under 510(k) number K981036.

Who is the listed applicant for SMARTBOND?

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

What is the FDA product code for SMARTBOND?

The FDA product code for SMARTBOND is DYH.

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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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