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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 K854613
Device Name SURGICAL DRAPES, OPHTHALMIN
Applicant
Charles Atkins & Co.
5801 Peachtree Dunwoody Rd.
Atlanta,  GA  30342
Applicant Contact CHARLES R ATKINS
Correspondent
Charles Atkins & Co.
5801 Peachtree Dunwoody Rd.
Atlanta,  GA  30342
Correspondent Contact CHARLES R ATKINS
Regulation Number878.4370
Classification Product Code
HMT  
Date Received11/18/1985
Decision Date 02/13/1986
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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