510(k) K020542

DAYTRIPPER DIALYSATE WARMER by Stickman Industries, Inc. — Product Code MLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2002
Date Received
February 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Peritoneal Dialysate
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type