510(k) K971100

ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR by Atrion Medical Products, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1997
Date Received
March 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type