510(k) K972867

CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT by Rocket Medical Plc — Product Code ICX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aniline
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type