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FDA 510(k)

GC RELINE SOFT/EXTRA SOFT

K-Number: K990736 · 1999-05-28

ApplicantGC America, Inc.
Decision Date1999-05-28
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC RELINE SOFT/EXTRA SOFT is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K990736. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC RELINE SOFT/EXTRA SOFT?

GC RELINE SOFT/EXTRA SOFT is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is GC America, Inc.. The 510(k) number is K990736.

When did GC RELINE SOFT/EXTRA SOFT receive FDA 510(k) clearance?

GC RELINE SOFT/EXTRA SOFT received FDA 510(k) clearance on 1999-05-28, under 510(k) number K990736.

Who is the listed applicant for GC RELINE SOFT/EXTRA SOFT?

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

What is the FDA product code for GC RELINE SOFT/EXTRA SOFT?

The FDA product code for GC RELINE SOFT/EXTRA SOFT is EBI.

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Other records listing GC America, Inc. as applicant

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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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