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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K875099
Device Name MOLTENO VALVE SETON
Applicant
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Applicant Contact JASON MALECKA
Correspondent
Staar Surgical Co.
1911 Walker Ave.
Monrovia,  CA  91016
Correspondent Contact JASON MALECKA
Regulation Number886.3920
Classification Product Code
KYF  
Date Received12/10/1987
Decision Date 03/30/1988
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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