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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 K860770
Device Name AM-100 I/A AMPAC
Applicant
Dravon Medical, Inc.
P.O. Box 69, 11465 SE
Hwy. 212
Clackamas,  OR  97015
Applicant Contact MADALYN C DUNCAN
Correspondent
Dravon Medical, Inc.
P.O. Box 69, 11465 SE
Hwy. 212
Clackamas,  OR  97015
Correspondent Contact MADALYN C DUNCAN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/03/1986
Decision Date 04/21/1986
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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