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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 K853189
Device Name CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
Applicant
Aesthetech Corp.
Post Office Box 278
634 Airport Rd.
Paso Robles,  CA  93447
Applicant Contact THOMAS D SALISBURY
Correspondent
Aesthetech Corp.
Post Office Box 278
634 Airport Rd.
Paso Robles,  CA  93447
Correspondent Contact THOMAS D SALISBURY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/30/1985
Decision Date 09/24/1985
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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