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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blade, scalpel
510(k) Number K032242
Device Name PERSONNA PLUS SAFETY SCALPEL SYSTEM
Applicant
OMI MANUFACTURING PTY., LTD.
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Regulation Number878.4800
Classification Product Code
GES  
Subsequent Product Code
GDZ  
Date Received07/21/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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