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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Nose, Internal
510(k) Number K880405
Device Name SILASTIC NASAL IMPLANT S-TYPE
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact LIPSCOMB, PHD
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact LIPSCOMB, PHD
Regulation Number878.3680
Classification Product Code
FZE  
Date Received01/29/1988
Decision Date 02/18/1988
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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