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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 K880329
Device Name FACTOR II PROSTHETIC SILICONE ELASTOMER
Applicant
Factor, Ii, Inc.
P.O. Box 1339
Lakeside,  AZ  85929
Applicant Contact JOHN MCFALL
Correspondent
Factor, Ii, Inc.
P.O. Box 1339
Lakeside,  AZ  85929
Correspondent Contact JOHN MCFALL
Regulation Number878.3800
Classification Product Code
GBI  
Date Received01/26/1988
Decision Date 06/01/1988
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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