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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Oral Cavity
510(k) Number K973248
Device Name IMTEC BONE COLLECTOR SYSTEM
Applicant
Imtec Corp.
2401 N. Commerce
P.O. Boxc 1562
Ardmore,  OK  73402
Applicant Contact M.K. PATTERSON
Correspondent
Imtec Corp.
2401 N. Commerce
P.O. Boxc 1562
Ardmore,  OK  73402
Correspondent Contact M.K. PATTERSON
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received08/29/1997
Decision Date 11/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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