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FDA 510(k)

FOLEY-TEMP(TM)

K-Number: K882130 · 1988-08-09

ApplicantMallinckroot, Inc.
Decision Date1988-08-09
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOLEY-TEMP(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckroot, Inc.. It received FDA 510(k) clearance on 1988-08-09 under 510(k) number K882130. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOLEY-TEMP(TM)?

FOLEY-TEMP(TM) is a medical device that received FDA 510(k) clearance on 1988-08-09. The listed applicant is Mallinckroot, Inc.. The 510(k) number is K882130.

When did FOLEY-TEMP(TM) receive FDA 510(k) clearance?

FOLEY-TEMP(TM) received FDA 510(k) clearance on 1988-08-09, under 510(k) number K882130.

Who is the listed applicant for FOLEY-TEMP(TM)?

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

What is the FDA product code for FOLEY-TEMP(TM)?

The FDA product code for FOLEY-TEMP(TM) is EYB.

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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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