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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K071491
Device Name ARROW INTERNATIONAL, INC., SURGICAL DRAPES
Applicant
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact KARL J NITTINGER
Correspondent
Arrow Intl., Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact KARL J NITTINGER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/30/2007
Decision Date 10/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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