FDA 510(k)

GC MODELS OPA-100 AND JC-50

K-Number: K073588 · 2008-02-15

Decision Date2008-02-15

Product CodeDYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GC MODELS OPA-100 AND JC-50 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 2008-02-15 under 510(k) number K073588. 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 GC MODELS OPA-100 AND JC-50?

GC MODELS OPA-100 AND JC-50 is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is GC America, Inc.. The 510(k) number is K073588.

When did GC MODELS OPA-100 AND JC-50 receive FDA 510(k) clearance?

GC MODELS OPA-100 AND JC-50 received FDA 510(k) clearance on 2008-02-15, under 510(k) number K073588.

Who is the listed applicant for GC MODELS OPA-100 AND JC-50?

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 MODELS OPA-100 AND JC-50?

The FDA product code for GC MODELS OPA-100 AND JC-50 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.