510(k) K841515

SCANLAN VASCU-STATT II by Scanlan Intl., Inc. — Product Code HRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1984
Date Received
April 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Engine, Trephine, Accessories, Ac-Powered
Device Class
Class I
Regulation Number
886.4070
Review Panel
OP
Submission Type