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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K971100
Device Name ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
Applicant
Atrion Medical Products, Inc.
1426 Curt Francis Rd.
Arab,  AL  35016
Applicant Contact DAN CLARKE
Correspondent
Atrion Medical Products, Inc.
1426 Curt Francis Rd.
Arab,  AL  35016
Correspondent Contact DAN CLARKE
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/26/1997
Decision Date 05/23/1997
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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