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FDA 510(k)

KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170

K-Number: K002221 · 2000-08-09

ApplicantHeinz Kurz GmbH Medizintechnik
Decision Date2000-08-09
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 is the device name listed in this FDA 510(k) record. The listed applicant is Heinz Kurz GmbH Medizintechnik. It received FDA 510(k) clearance on 2000-08-09 under 510(k) number K002221. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170?

KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 is a medical device that received FDA 510(k) clearance on 2000-08-09. The listed applicant is Heinz Kurz GmbH Medizintechnik. The 510(k) number is K002221.

When did KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 receive FDA 510(k) clearance?

KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 received FDA 510(k) clearance on 2000-08-09, under 510(k) number K002221.

Who is the listed applicant for KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170?

The FDA 510(k) record lists Heinz Kurz GmbH Medizintechnik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170?

The FDA product code for KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 is ETB.

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Other records listing Heinz Kurz GmbH Medizintechnik as applicant

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K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISK112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISK071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIREK042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMK033796KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BSK021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861

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Official Source

View on FDA Database →

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