FDA 510(k)

H/A TOTAL-REGULAR, H/A TOTAL-OFFSET

K-Number: K913286 · 1991-12-18

Decision Date1991-12-18

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

H/A TOTAL-REGULAR, H/A TOTAL-OFFSET is the device name listed in this FDA 510(k) record. The listed applicant is River Medical, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K913286. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H/A TOTAL-REGULAR, H/A TOTAL-OFFSET?

H/A TOTAL-REGULAR, H/A TOTAL-OFFSET is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is River Medical, Inc.. The 510(k) number is K913286.

When did H/A TOTAL-REGULAR, H/A TOTAL-OFFSET receive FDA 510(k) clearance?

H/A TOTAL-REGULAR, H/A TOTAL-OFFSET received FDA 510(k) clearance on 1991-12-18, under 510(k) number K913286.

Who is the listed applicant for H/A TOTAL-REGULAR, H/A TOTAL-OFFSET?

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

What is the FDA product code for H/A TOTAL-REGULAR, H/A TOTAL-OFFSET?

The FDA product code for H/A TOTAL-REGULAR, H/A TOTAL-OFFSET is ETA.

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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.