FDA 510(k)

ALUMINA SILICA-ACTIVATED PARTIAL THROM

K-Number: K820835 · 1982-04-26

ApplicantHyland Therapeutic Div., Travenol Laboratories

Decision Date1982-04-26

Product CodeGFO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ALUMINA SILICA-ACTIVATED PARTIAL THROM is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1982-04-26 under 510(k) number K820835. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALUMINA SILICA-ACTIVATED PARTIAL THROM?

ALUMINA SILICA-ACTIVATED PARTIAL THROM is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K820835.

When did ALUMINA SILICA-ACTIVATED PARTIAL THROM receive FDA 510(k) clearance?

ALUMINA SILICA-ACTIVATED PARTIAL THROM received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820835.

Who is the listed applicant for ALUMINA SILICA-ACTIVATED PARTIAL THROM?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALUMINA SILICA-ACTIVATED PARTIAL THROM?

The FDA product code for ALUMINA SILICA-ACTIVATED PARTIAL THROM is GFO.

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Official Source

View on FDA Database →

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