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FDA 510(k)

ASSURE LEVEL II PROD. #30172

K-Number: K801539 · 1980-09-09

ApplicantWarner-Lambert Co.
Decision Date1980-09-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSURE LEVEL II PROD. #30172 is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801539. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSURE LEVEL II PROD. #30172?

ASSURE LEVEL II PROD. #30172 is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Warner-Lambert Co.. The 510(k) number is K801539.

When did ASSURE LEVEL II PROD. #30172 receive FDA 510(k) clearance?

ASSURE LEVEL II PROD. #30172 received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801539.

Who is the listed applicant for ASSURE LEVEL II PROD. #30172?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSURE LEVEL II PROD. #30172?

The FDA product code for ASSURE LEVEL II PROD. #30172 is JJY.

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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.

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