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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter
510(k) Number K781846
Device Name ADAPTER, CATHETER SHEATH
Applicant
ARROW INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ARROW INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received11/01/1978
Decision Date 12/12/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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