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FDA 510(k)

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)

K-Number: K101547 · 2010-11-22

ApplicantHenke-Sass, Wolf GmbH
Decision Date2010-11-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) is the device name listed in this FDA 510(k) record. The listed applicant is Henke-Sass, Wolf GmbH. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K101547. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)?

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Henke-Sass, Wolf GmbH. The 510(k) number is K101547.

When did HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) receive FDA 510(k) clearance?

HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) received FDA 510(k) clearance on 2010-11-22, under 510(k) number K101547.

Who is the listed applicant for HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)?

The FDA 510(k) record lists Henke-Sass, Wolf GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)?

The FDA product code for HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) is FMF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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