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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 S.E.
HIGHWAY 212
CLACKAMAS,  OR  97015
Applicant Contact MADALYN C DUNCAN
Correspondent
DRAVON MEDICAL, INC.
P.O. BOX 69, 11465 S.E.
HIGHWAY 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
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