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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 K770359
Device Name IMPLANTING OF POLYACRYLIC FIBERS
Applicant
Allan V. Marse
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Allan V. Marse
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.3800
Classification Product Code
GBI  
Date Received02/22/1977
Decision Date 04/08/1977
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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