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FDA 510(k)

OVU-GUIDE

K-Number: K781817 · 1978-12-04

ApplicantReproduction Research Laboratories
Decision Date1978-12-04
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OVU-GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Reproduction Research Laboratories. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781817. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVU-GUIDE?

OVU-GUIDE is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Reproduction Research Laboratories. The 510(k) number is K781817.

When did OVU-GUIDE receive FDA 510(k) clearance?

OVU-GUIDE received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781817.

Who is the listed applicant for OVU-GUIDE?

The FDA 510(k) record lists Reproduction Research Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OVU-GUIDE?

The FDA product code for OVU-GUIDE is FLK.

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Related Devices (Code: FLK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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