SHARPSAWAY II LOCKING DISPOSABLE CUP

Needle, Hypodermic, Single Lumen

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Sharpsaway Ii Locking Disposable Cup.

Pre-market Notification Details

Device IDK041153
510k NumberK041153
Device Name:SHARPSAWAY II LOCKING DISPOSABLE CUP
ClassificationNeedle, Hypodermic, Single Lumen
Applicant ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactElizabeth Price
CorrespondentElizabeth Price
ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-03
Decision Date2004-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20801902025702 K041153 000
20801902113003 K041153 000
20801902143574 K041153 000
20801902158851 K041153 000
30801902131110 K041153 000

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