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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical
510(k) Number K933298
Device Name SAW BLADE
Applicant
Omega Surgical Instruments, Inc.
11415 Orchardview Dr.
Fenton,  MI  48430
Applicant Contact GARY L ADAM
Correspondent
Omega Surgical Instruments, Inc.
11415 Orchardview Dr.
Fenton,  MI  48430
Correspondent Contact GARY L ADAM
Regulation Number878.4820
Classification Product Code
GFA  
Date Received07/07/1993
Decision Date 08/09/1993
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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