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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 K841072
Device Name IRRIGATION, ASPIRATION TUBING SETS
Applicant
Innovative Surgical Products, Inc.
1201 E. Wakeham
Santa Ana,  CA  92705
Applicant Contact DUANE MASON
Correspondent
Innovative Surgical Products, Inc.
1201 E. Wakeham
Santa Ana,  CA  92705
Correspondent Contact DUANE MASON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/12/1984
Decision Date 03/29/1984
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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