510(k) K020542
- Device
- DAYTRIPPER DIALYSATE WARMER
- Applicant
- STICKMAN INDUSTRIES INC.
- 510(k) number
- K020542
- Product code
- MLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-27
- Date received
- 2002-02-19
- Regulation
- 876.5630
- Classification name
- Warmer, Peritoneal Dialysate
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEAN CLERMONT
- Address
- 320 Lanark Ave. Ottawa, Ontario CA K1Z 6R5 K1Z 6R5
FDA Registration Numbers#
- 3005699784
- 3012706378
- 3014377913
- 3006986257
- 3003661577
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MLW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions, LLC | 2025-05-05 |
| K131583 | THERMOCHEM HT-2000 | Thermasolutions, Inc. | 2013-10-03 |
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 |
| K964825 | FREEDOM TRAVELLER | Impact Case Technologies, Inc. | 1997-05-19 |
| K933619 | PD-PAK | General Medical Mfg. Co. | 1994-02-22 |
Legacy Summary#
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FDA Review#
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