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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K851203
Device Name R PAK
Applicant
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Applicant Contact DAVID W KRAPP
Correspondent
CooperVision, Inc.
17701 Cowan Ave.P. O. Box
19587
Irvine,  CA  92713
Correspondent Contact DAVID W KRAPP
Classification Product Code
LFL  
Date Received03/26/1985
Decision Date 07/23/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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