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FDA 510(k)

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS

K-Number: K033796 · 2004-01-30

ApplicantHeinz Kurz GmbH Medizintechnik
Decision Date2004-01-30
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS 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 2004-01-30 under 510(k) number K033796. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS?

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS is a medical device that received FDA 510(k) clearance on 2004-01-30. The listed applicant is Heinz Kurz GmbH Medizintechnik. The 510(k) number is K033796.

When did KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS receive FDA 510(k) clearance?

KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS received FDA 510(k) clearance on 2004-01-30, under 510(k) number K033796.

Who is the listed applicant for KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS?

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 KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS?

The FDA product code for KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS is KHJ.

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Other records listing Heinz Kurz GmbH Medizintechnik as applicant

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Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.

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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