The following data is part of a premarket notification filed by Stickman Industries Inc. with the FDA for Daytripper Dialysate Warmer.
Device ID | K020542 |
510k Number | K020542 |
Device Name: | DAYTRIPPER DIALYSATE WARMER |
Classification | Warmer, Peritoneal Dialysate |
Applicant | STICKMAN INDUSTRIES INC. 320 LANARK AVENUE Ottawa, Ontario, CA K1z 6r5 |
Contact | Jean Clermont |
Correspondent | Jean Clermont STICKMAN INDUSTRIES INC. 320 LANARK AVENUE Ottawa, Ontario, CA K1z 6r5 |
Product Code | MLW |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-19 |
Decision Date | 2002-09-27 |