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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 K870806
Device Name NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
Applicant
United Surgical Corp.
15500-A Rockfield Blvd.
Irvine,  CA  92718
Applicant Contact TERRY F HERBECK
Correspondent
United Surgical Corp.
15500-A Rockfield Blvd.
Irvine,  CA  92718
Correspondent Contact TERRY F HERBECK
Regulation Number886.4670
Classification Product Code
HQC  
Date Received02/26/1987
Decision Date 03/26/1987
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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