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FDA 510(k)

INCLUSICE II(TM) ENDOSCOPE

K-Number: K946087 · 1995-11-21

ApplicantSofamor Danek USA,Inc.
Decision Date1995-11-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INCLUSICE II(TM) ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1995-11-21 under 510(k) number K946087. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCLUSICE II(TM) ENDOSCOPE?

INCLUSICE II(TM) ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K946087.

When did INCLUSICE II(TM) ENDOSCOPE receive FDA 510(k) clearance?

INCLUSICE II(TM) ENDOSCOPE received FDA 510(k) clearance on 1995-11-21, under 510(k) number K946087.

Who is the listed applicant for INCLUSICE II(TM) ENDOSCOPE?

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

What is the FDA product code for INCLUSICE II(TM) ENDOSCOPE?

The FDA product code for INCLUSICE II(TM) ENDOSCOPE is HRX.

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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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