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FDA 510(k)

COBE ACUFLEX SSN, #15-220

K-Number: K820238 · 1982-03-10

ApplicantCobe Laboratories, Inc.
Decision Date1982-03-10
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE ACUFLEX SSN, #15-220 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1982-03-10 under 510(k) number K820238. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE ACUFLEX SSN, #15-220?

COBE ACUFLEX SSN, #15-220 is a medical device that received FDA 510(k) clearance on 1982-03-10. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K820238.

When did COBE ACUFLEX SSN, #15-220 receive FDA 510(k) clearance?

COBE ACUFLEX SSN, #15-220 received FDA 510(k) clearance on 1982-03-10, under 510(k) number K820238.

Who is the listed applicant for COBE ACUFLEX SSN, #15-220?

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

What is the FDA product code for COBE ACUFLEX SSN, #15-220?

The FDA product code for COBE ACUFLEX SSN, #15-220 is LFJ.

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Other records listing Cobe Laboratories, 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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