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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Patient, Ophthalmic
510(k) Number K871706
Device Name OPTHA PREP
Applicant
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Applicant Contact THOMAS, JR
Correspondent
Treace Medical, Inc.
Suite 400
22 N. Second St.
Memphis,  TN  38103
Correspondent Contact THOMAS, JR
Regulation Number878.4370
Classification Product Code
HMT  
Date Received05/01/1987
Decision Date 05/18/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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