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FDA 510(k)

SPRYTIE, MODELS ST001, ST002 AND ST003

K-Number: K092530 · 2010-04-02

ApplicantRussell B. Walther
Decision Date2010-04-02
Product CodeDZK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPRYTIE, MODELS ST001, ST002 AND ST003 is the device name listed in this FDA 510(k) record. The listed applicant is Russell B. Walther. It received FDA 510(k) clearance on 2010-04-02 under 510(k) number K092530. The device is classified under product code DZK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPRYTIE, MODELS ST001, ST002 AND ST003?

SPRYTIE, MODELS ST001, ST002 AND ST003 is a medical device that received FDA 510(k) clearance on 2010-04-02. The listed applicant is Russell B. Walther. The 510(k) number is K092530.

When did SPRYTIE, MODELS ST001, ST002 AND ST003 receive FDA 510(k) clearance?

SPRYTIE, MODELS ST001, ST002 AND ST003 received FDA 510(k) clearance on 2010-04-02, under 510(k) number K092530.

Who is the listed applicant for SPRYTIE, MODELS ST001, ST002 AND ST003?

The FDA 510(k) record lists Russell B. Walther as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPRYTIE, MODELS ST001, ST002 AND ST003?

The FDA product code for SPRYTIE, MODELS ST001, ST002 AND ST003 is DZK.

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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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