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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bur, surgical, general & plastic surgery
510(k) Number K934583
Device Name BURRS
Applicant
AMERICAN MEDICAL SPECIALTIES, INC.
1080 HOLCOMB BRIDGE ROAD.
BLDG. 100 STE. 300
ROSWELL,  GA  30076
Applicant Contact ROGER EAGLEN
Correspondent
AMERICAN MEDICAL SPECIALTIES, INC.
1080 HOLCOMB BRIDGE ROAD.
BLDG. 100 STE. 300
ROSWELL,  GA  30076
Correspondent Contact ROGER EAGLEN
Regulation Number878.4820
Classification Product Code
GFF  
Date Received09/23/1993
Decision Date 01/26/1994
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
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