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FDA 510(k)

CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861

K-Number: K021479 · 2002-05-21

ApplicantHeinz Kurz GmbH Medizintechnik
Decision Date2002-05-21
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 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 2002-05-21 under 510(k) number K021479. 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 CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861?

CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 is a medical device that received FDA 510(k) clearance on 2002-05-21. The listed applicant is Heinz Kurz GmbH Medizintechnik. The 510(k) number is K021479.

When did CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 receive FDA 510(k) clearance?

CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 received FDA 510(k) clearance on 2002-05-21, under 510(k) number K021479.

Who is the listed applicant for CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861?

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 CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861?

The FDA product code for CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 is ETB.

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Other records listing Heinz Kurz GmbH Medizintechnik as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 BSK013573CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257

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Related Devices (Code: ETB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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