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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K880961
Device Name ALCON SURGICAL PROCEDURE PACKS
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
PO BOX 6600
FORT WORTH,  TX  76134 -2099
Applicant Contact REBECCA G WALKER
Correspondent
ALCON LABORATORIES
6201 SOUTH FREEWAY
PO BOX 6600
FORT WORTH,  TX  76134 -2099
Correspondent Contact REBECCA G WALKER
Regulation Number878.4370
Classification Product Code
LRO  
Date Received03/08/1988
Decision Date 04/29/1988
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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