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FDA 510(k)

HYDROPREP GEL

K-Number: K964737 · 1997-03-19

ApplicantD.O. Weaver Co.
Decision Date1997-03-19
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HYDROPREP GEL is the device name listed in this FDA 510(k) record. The listed applicant is D.O. Weaver Co.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K964737. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROPREP GEL?

HYDROPREP GEL is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is D.O. Weaver Co.. The 510(k) number is K964737.

When did HYDROPREP GEL receive FDA 510(k) clearance?

HYDROPREP GEL received FDA 510(k) clearance on 1997-03-19, under 510(k) number K964737.

Who is the listed applicant for HYDROPREP GEL?

The FDA 510(k) record lists D.O. Weaver Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROPREP GEL?

The FDA product code for HYDROPREP GEL is GYB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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