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FDA 510(k)

BAXA ADLI SEAL

K-Number: K813435 · 1981-12-18

ApplicantBaxa Corp., Sub. of Cook Group, Inc.
Decision Date1981-12-18
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAXA ADLI SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813435. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXA ADLI SEAL?

BAXA ADLI SEAL is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. The 510(k) number is K813435.

When did BAXA ADLI SEAL receive FDA 510(k) clearance?

BAXA ADLI SEAL received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813435.

Who is the listed applicant for BAXA ADLI SEAL?

The FDA 510(k) record lists Baxa Corp., Sub. of Cook Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAXA ADLI SEAL?

The FDA product code for BAXA ADLI SEAL is KPE.

Other records listing Baxa Corp., Sub. of Cook Group, 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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