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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
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