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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 K872362
Device Name FRIGITRONICS ACC-1000 CAPSULE CUTTER
Applicant
Frigitronics of Connecticut, Inc.
770 River Rd.
P.O. Box 855
Shelton,  CT  06484
Applicant Contact CLIFFORD F POTOCKY
Correspondent
Frigitronics of Connecticut, Inc.
770 River Rd.
P.O. Box 855
Shelton,  CT  06484
Correspondent Contact CLIFFORD F POTOCKY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received06/18/1987
Decision Date 07/27/1987
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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