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FDA 510(k)

MIST REDUCER SLEEVES

K-Number: K951398 · 1995-05-03

ApplicantMinimally Invasive Surgical Technologies, Inc.
Decision Date1995-05-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MIST REDUCER SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is Minimally Invasive Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K951398. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIST REDUCER SLEEVES?

MIST REDUCER SLEEVES is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Minimally Invasive Surgical Technologies, Inc.. The 510(k) number is K951398.

When did MIST REDUCER SLEEVES receive FDA 510(k) clearance?

MIST REDUCER SLEEVES received FDA 510(k) clearance on 1995-05-03, under 510(k) number K951398.

Who is the listed applicant for MIST REDUCER SLEEVES?

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

What is the FDA product code for MIST REDUCER SLEEVES?

The FDA product code for MIST REDUCER SLEEVES is GCJ.

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Other records listing Minimally Invasive Surgical Technologies, Inc. as applicant

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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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