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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 K945154
Device Name BA-CPAS
Applicant
Nobelpharma USA, Inc.
777 Oakmont Ln., Suite 100
Westmont,  IL  60559
Applicant Contact MARY EDWARDS
Correspondent
Nobelpharma USA, Inc.
777 Oakmont Ln., Suite 100
Westmont,  IL  60559
Correspondent Contact MARY EDWARDS
Regulation Number878.3680
Classification Product Code
FZE  
Date Received10/21/1994
Decision Date 01/13/1995
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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