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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, External Aesthetic Restoration, Used With Adhesive
510(k) Number K874279
Device Name AHH NATURAL BREAST FORM
Applicant
Pacific Prosthetics, Inc.
511 E. Gutierrez St. #4
Santa Barbara,  CA  93103
Applicant Contact WILLIAM PAINTER
Correspondent
Pacific Prosthetics, Inc.
511 E. Gutierrez St. #4
Santa Barbara,  CA  93103
Correspondent Contact WILLIAM PAINTER
Regulation Number878.3800
Classification Product Code
GBI  
Date Received10/20/1987
Decision Date 10/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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