FDA 510(k)

TREBAY TOTAL RECTANGULAR HEAD

K-Number: K954518 · 1995-10-27

Decision Date1995-10-27

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

TREBAY TOTAL RECTANGULAR HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Trebay Medical Corp.. It received FDA 510(k) clearance on 1995-10-27 under 510(k) number K954518. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREBAY TOTAL RECTANGULAR HEAD?

TREBAY TOTAL RECTANGULAR HEAD is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Trebay Medical Corp.. The 510(k) number is K954518.

When did TREBAY TOTAL RECTANGULAR HEAD receive FDA 510(k) clearance?

TREBAY TOTAL RECTANGULAR HEAD received FDA 510(k) clearance on 1995-10-27, under 510(k) number K954518.

Who is the listed applicant for TREBAY TOTAL RECTANGULAR HEAD?

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

What is the FDA product code for TREBAY TOTAL RECTANGULAR HEAD?

The FDA product code for TREBAY TOTAL RECTANGULAR HEAD is ETA.

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Other records listing Trebay Medical Corp. as applicant

K955704TREBAY MICRODEBRIDER SYSTEM K955294SOF - ABRASION BUR K955560TREBAY SCOPE IRRIGATED CLEARING SLEEVE K955447TYMPANOSTOMY TUBE K954912TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)K954795AT2 & DOYLE STYLE (C-FLEX) VENT TUBES

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Related Devices (Code: ETA)

K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50MED-EL Elektromedizinische Geräte GmbH K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH K091187GRACE DYNAMIC TORPGrace Medical, Inc.K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz Endoscopy K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik

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.