FDA 510(k)

PAKOSTAT II

K-Number: K760846 · 1977-01-07

Decision Date1977-01-07

Product CodeEGW

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PAKOSTAT II is the device name listed in this FDA 510(k) record. The listed applicant is Pako Corp.. It received FDA 510(k) clearance on 1977-01-07 under 510(k) number K760846. The device is classified under product code EGW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAKOSTAT II?

PAKOSTAT II is a medical device that received FDA 510(k) clearance on 1977-01-07. The listed applicant is Pako Corp.. The 510(k) number is K760846.

When did PAKOSTAT II receive FDA 510(k) clearance?

PAKOSTAT II received FDA 510(k) clearance on 1977-01-07, under 510(k) number K760846.

Who is the listed applicant for PAKOSTAT II?

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

What is the FDA product code for PAKOSTAT II?

The FDA product code for PAKOSTAT II is EGW.

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Related Devices (Code: EGW)

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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.