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FDA 510(k)

GILL-THOMAS-COSMAN(GTC) DENTAL TRAY

K-Number: K962155 · 1996-08-22

ApplicantRadionics Software Applications, Inc.
Decision Date1996-08-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GILL-THOMAS-COSMAN(GTC) DENTAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1996-08-22 under 510(k) number K962155. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILL-THOMAS-COSMAN(GTC) DENTAL TRAY?

GILL-THOMAS-COSMAN(GTC) DENTAL TRAY is a medical device that received FDA 510(k) clearance on 1996-08-22. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K962155.

When did GILL-THOMAS-COSMAN(GTC) DENTAL TRAY receive FDA 510(k) clearance?

GILL-THOMAS-COSMAN(GTC) DENTAL TRAY received FDA 510(k) clearance on 1996-08-22, under 510(k) number K962155.

Who is the listed applicant for GILL-THOMAS-COSMAN(GTC) DENTAL TRAY?

The FDA 510(k) record lists Radionics Software Applications, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GILL-THOMAS-COSMAN(GTC) DENTAL TRAY?

The FDA product code for GILL-THOMAS-COSMAN(GTC) DENTAL TRAY is IYE.

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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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