FDA 510(k)

HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX

K-Number: K853731 · 1985-10-18

Decision Date1985-10-18

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1985-10-18 under 510(k) number K853731. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX?

HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX is a medical device that received FDA 510(k) clearance on 1985-10-18. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K853731.

When did HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX receive FDA 510(k) clearance?

HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX received FDA 510(k) clearance on 1985-10-18, under 510(k) number K853731.

Who is the listed applicant for HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX?

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

What is the FDA product code for HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX?

The FDA product code for HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX is FMI.

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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.