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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K882372
Device Name RESUBMITTED DIODE LASER COAGULATOR
Applicant
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Applicant Contact DAVID KRAPF
Correspondent
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Correspondent Contact DAVID KRAPF
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/26/1988
Decision Date 08/02/1988
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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