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FDA 510(k)

PURGE LINE UNIT

K-Number: K790804 · 1979-05-25

ApplicantSurgikos, Inc.
Decision Date1979-05-25
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PURGE LINE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1979-05-25 under 510(k) number K790804. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURGE LINE UNIT?

PURGE LINE UNIT is a medical device that received FDA 510(k) clearance on 1979-05-25. The listed applicant is Surgikos, Inc.. The 510(k) number is K790804.

When did PURGE LINE UNIT receive FDA 510(k) clearance?

PURGE LINE UNIT received FDA 510(k) clearance on 1979-05-25, under 510(k) number K790804.

Who is the listed applicant for PURGE LINE UNIT?

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

What is the FDA product code for PURGE LINE UNIT?

The FDA product code for PURGE LINE UNIT is DTL.

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Other records listing Surgikos, Inc. as applicant

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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.

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