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FDA 510(k)

INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS

K-Number: K952889 · 1995-12-22

ApplicantMaterials Conversion Corp.
Decision Date1995-12-22
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Materials Conversion Corp.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K952889. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS?

INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Materials Conversion Corp.. The 510(k) number is K952889.

When did INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS receive FDA 510(k) clearance?

INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS received FDA 510(k) clearance on 1995-12-22, under 510(k) number K952889.

Who is the listed applicant for INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS?

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

What is the FDA product code for INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS?

The FDA product code for INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS is HET.

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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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