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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K882558
Device Name AREOLA/NIPPLE DRESSING
Applicant
Cooper Surgical/Aesthete
Post Office Box 278
634 Airport Rd.
Paso Robles,  CA  93447
Applicant Contact THOMAS D SALISBURY
Correspondent
Cooper Surgical/Aesthete
Post Office Box 278
634 Airport Rd.
Paso Robles,  CA  93447
Correspondent Contact THOMAS D SALISBURY
Regulation Number878.4020
Classification Product Code
NAD  
Date Received06/21/1988
Decision Date 05/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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