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FDA 510(k)

HYDROFLEX

K-Number: K970656 · 1997-04-08

ApplicantGC America, Inc.
Decision Date1997-04-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROFLEX 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 1997-04-08 under 510(k) number K970656. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROFLEX?

HYDROFLEX is a medical device that received FDA 510(k) clearance on 1997-04-08. The listed applicant is GC America, Inc.. The 510(k) number is K970656.

When did HYDROFLEX receive FDA 510(k) clearance?

HYDROFLEX received FDA 510(k) clearance on 1997-04-08, under 510(k) number K970656.

Who is the listed applicant for HYDROFLEX?

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 HYDROFLEX?

The FDA product code for HYDROFLEX is ELW.

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Related Devices (Code: ELW)

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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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