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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K003512
Device Name LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
Applicant
A.R.C. LASER AG
2417 SOUTH 3850 WEST
SALT LAKE CITY,  UT  84120
Applicant Contact DANIEL HOEFER
Correspondent
A.R.C. LASER AG
2417 SOUTH 3850 WEST
SALT LAKE CITY,  UT  84120
Correspondent Contact DANIEL HOEFER
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
GEX  
Date Received11/14/2000
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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