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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852187
Device Name SITE INFUSION CONTACT LENS W/ILLUMINATOR
Applicant
Microsurgical Systems, Inc.
135 Gilbraltar Rd.
Horsham,  PA  19044
Applicant Contact JAMES MCCRACKEN
Correspondent
Microsurgical Systems, Inc.
135 Gilbraltar Rd.
Horsham,  PA  19044
Correspondent Contact JAMES MCCRACKEN
Date Received05/20/1985
Decision Date 07/31/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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