The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Patient Warming System - Model 100 Control Unit And Energy Transfer Pads.
Device ID | K033021 |
510k Number | K033021 |
Device Name: | KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS |
Classification | System, Thermal Regulating |
Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
Contact | Richard V Wolfe |
Correspondent | Richard V Wolfe KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-26 |
Decision Date | 2003-11-12 |
Summary: | summary |