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FDA 510(k)

WAVICIDE(R) -01

K-Number: K914749 · 1995-08-10

ApplicantWave Energy Systems, Inc.
Decision Date1995-08-10
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WAVICIDE(R) -01 is the device name listed in this FDA 510(k) record. The listed applicant is Wave Energy Systems, Inc.. It received FDA 510(k) clearance on 1995-08-10 under 510(k) number K914749. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVICIDE(R) -01?

WAVICIDE(R) -01 is a medical device that received FDA 510(k) clearance on 1995-08-10. The listed applicant is Wave Energy Systems, Inc.. The 510(k) number is K914749.

When did WAVICIDE(R) -01 receive FDA 510(k) clearance?

WAVICIDE(R) -01 received FDA 510(k) clearance on 1995-08-10, under 510(k) number K914749.

Who is the listed applicant for WAVICIDE(R) -01?

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

What is the FDA product code for WAVICIDE(R) -01?

The FDA product code for WAVICIDE(R) -01 is MED.

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Official Source

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