FDA 510(k)

SHARPSAWAY II LOCKING DISPOSABLE CUP

K-Number: K041153 · 2004-07-12

Decision Date2004-07-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SHARPSAWAY II LOCKING DISPOSABLE CUP is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2004-07-12 under 510(k) number K041153. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPSAWAY II LOCKING DISPOSABLE CUP?

SHARPSAWAY II LOCKING DISPOSABLE CUP is a medical device that received FDA 510(k) clearance on 2004-07-12. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K041153.

When did SHARPSAWAY II LOCKING DISPOSABLE CUP receive FDA 510(k) clearance?

SHARPSAWAY II LOCKING DISPOSABLE CUP received FDA 510(k) clearance on 2004-07-12, under 510(k) number K041153.

Who is the listed applicant for SHARPSAWAY II LOCKING DISPOSABLE CUP?

The FDA 510(k) record lists Arrow Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHARPSAWAY II LOCKING DISPOSABLE CUP?

The FDA product code for SHARPSAWAY II LOCKING DISPOSABLE CUP is FMI.

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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.