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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(k) Number K022777
Device Name MANUAL TOUCHE SYSTEM
Applicant
Onux Medical, Inc.
5 Merrill Dr.
Hampton,  NH  03842
Applicant Contact RUTHANN DEPIETRO
Correspondent
Onux Medical, Inc.
5 Merrill Dr.
Hampton,  NH  03842
Correspondent Contact RUTHANN DEPIETRO
Regulation Number878.4495
Classification Product Code
GAQ  
Subsequent Product Code
HCF  
Date Received08/21/2002
Decision Date 11/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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