ARROW INTERNATIONAL, INC., SURGICAL DRAPES

Drape, Surgical

ARROW INTL., INC.

The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow International, Inc., Surgical Drapes.

Pre-market Notification Details

Device IDK071491
510k NumberK071491
Device Name:ARROW INTERNATIONAL, INC., SURGICAL DRAPES
ClassificationDrape, Surgical
Applicant ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
ContactKarl J Nittinger
CorrespondentKarl J Nittinger
ARROW INTL., INC. 2400 BERNVILLE RD. Reading,  PA  19605
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-30
Decision Date2007-10-10
Summary:summary

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