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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, air handling, enclosure
510(k) Number K854159
Device Name ELLIPTI-PUNCH
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH,  TX  76134 -2099
Applicant Contact REBECCA G WALKER
Correspondent
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH,  TX  76134 -2099
Correspondent Contact REBECCA G WALKER
Regulation Number878.5070
Classification Product Code
FZI  
Date Received10/11/1985
Decision Date 11/15/1985
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
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