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FDA 510(k)

AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY

K-Number: K870397 · 1987-03-18

ApplicantSunkey Medical Manufacturing, Inc.
Decision Date1987-03-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY is the device name listed in this FDA 510(k) record. The listed applicant is Sunkey Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 1987-03-18 under 510(k) number K870397. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY?

AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY is a medical device that received FDA 510(k) clearance on 1987-03-18. The listed applicant is Sunkey Medical Manufacturing, Inc.. The 510(k) number is K870397.

When did AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY receive FDA 510(k) clearance?

AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY received FDA 510(k) clearance on 1987-03-18, under 510(k) number K870397.

Who is the listed applicant for AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY?

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

What is the FDA product code for AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY?

The FDA product code for AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY is GEI.

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Official Source

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