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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystotome
510(k) Number K852934
Device Name PRECISION - COSMET CAPSULE COUPEUR
Applicant
PRECISION-COSMET CO., INC.
11140 BREN RD. W.
MINNETONKA,  MN  55343
Applicant Contact ROBERT L ULLEN
Correspondent
PRECISION-COSMET CO., INC.
11140 BREN RD. W.
MINNETONKA,  MN  55343
Correspondent Contact ROBERT L ULLEN
Regulation Number886.4350
Classification Product Code
HNY  
Date Received07/09/1985
Decision Date 08/08/1985
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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