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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 K934603
Device Name SURGICAL SAW BLADES
Applicant
American Medical Specialties, Inc.
1080 Holcomb Bridge Rd..
Bldg. 100 Suite 300
Roswell,  GA  30076
Applicant Contact ROGER EAGLEN
Correspondent
American Medical Specialties, Inc.
1080 Holcomb Bridge Rd..
Bldg. 100 Suite 300
Roswell,  GA  30076
Correspondent Contact ROGER EAGLEN
Regulation Number878.4820
Classification Product Code
GFA  
Date Received09/24/1993
Decision Date 02/22/1994
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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