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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cannula, Ophthalmic
510(k) Number K872884
Device Name LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
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
HMX  
Date Received07/22/1987
Decision Date 08/10/1987
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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