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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 K870439
Device Name LOOK IRRIGATING CYSTOTOMES
Applicant
Look, Inc.
45 Charles Park Rd.
Boston,  MA  02132
Applicant Contact DAVID H BARRETT
Correspondent
Look, Inc.
45 Charles Park Rd.
Boston,  MA  02132
Correspondent Contact DAVID H BARRETT
Regulation Number886.4350
Classification Product Code
HNY  
Date Received02/03/1987
Decision Date 02/20/1987
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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