FDA 510(k)

COOL CUT

K-Number: K931429 · 1994-04-29

ApplicantMitab

Decision Date1994-04-29

Product CodeHWE

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COOL CUT is the device name listed in this FDA 510(k) record. The listed applicant is Mitab. It received FDA 510(k) clearance on 1994-04-29 under 510(k) number K931429. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOL CUT?

COOL CUT is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Mitab. The 510(k) number is K931429.

When did COOL CUT receive FDA 510(k) clearance?

COOL CUT received FDA 510(k) clearance on 1994-04-29, under 510(k) number K931429.

Who is the listed applicant for COOL CUT?

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

What is the FDA product code for COOL CUT?

The FDA product code for COOL CUT is HWE.

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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.