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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 K002986
Device Name A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
Applicant
A.R.C. Laser AG
2417 S. 3850 W.
Salt Lake City,  UT  84120
Applicant Contact DANIEL HOEFER
Correspondent
A.R.C. Laser AG
2417 S. 3850 W.
Salt Lake City,  UT  84120
Correspondent Contact DANIEL HOEFER
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/25/2000
Decision Date 11/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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