FDA 510(k)

MEDI-LET

K-Number: K880869 · 1988-03-21

Decision Date1988-03-21

Product CodeFMK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEDI-LET is the device name listed in this FDA 510(k) record. The listed applicant is Medicore, Inc.. It received FDA 510(k) clearance on 1988-03-21 under 510(k) number K880869. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-LET?

MEDI-LET is a medical device that received FDA 510(k) clearance on 1988-03-21. The listed applicant is Medicore, Inc.. The 510(k) number is K880869.

When did MEDI-LET receive FDA 510(k) clearance?

MEDI-LET received FDA 510(k) clearance on 1988-03-21, under 510(k) number K880869.

Who is the listed applicant for MEDI-LET?

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

What is the FDA product code for MEDI-LET?

The FDA product code for MEDI-LET is FMK.

Other records listing Medicore, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983430LITE-TOUCH SYRINGE K810681MEDI-LANCE

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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.