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FDA 510(k)

NATURE-CRYL HI PLUS

K-Number: K051358 · 2005-07-07

ApplicantGC America, Inc.
Decision Date2005-07-07
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NATURE-CRYL HI PLUS 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 2005-07-07 under 510(k) number K051358. 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 NATURE-CRYL HI PLUS?

NATURE-CRYL HI PLUS is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is GC America, Inc.. The 510(k) number is K051358.

When did NATURE-CRYL HI PLUS receive FDA 510(k) clearance?

NATURE-CRYL HI PLUS received FDA 510(k) clearance on 2005-07-07, under 510(k) number K051358.

Who is the listed applicant for NATURE-CRYL HI PLUS?

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 NATURE-CRYL HI PLUS?

The FDA product code for NATURE-CRYL HI PLUS is EBI.

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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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