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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 K983755
Device Name NASAL DORSAL SERIES
Applicant
Surgical Technology Laboratories, Inc.
1588 E. 40th St.
Cleveland,  OH  44103
Applicant Contact RICHARD T NOCK
Correspondent
Surgical Technology Laboratories, Inc.
1588 E. 40th St.
Cleveland,  OH  44103
Correspondent Contact RICHARD T NOCK
Regulation Number878.3680
Classification Product Code
FZE  
Date Received10/22/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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