510(k) K922404

TUBE GRIP by Georgia Medical Products, Inc. — Product Code KRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1992
Date Received
May 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type