510(k) K964825
- Device
- FREEDOM TRAVELLER
- Applicant
- IMPACT CASE TECHNOLOGIES, INC.
- 510(k) number
- K964825
- Product code
- MLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-19
- Date received
- 1996-12-02
- 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
- ANGELA HAMLEN
- Address
- 20 Steelcase Rd., W., Units 6 & 7 Markham, Ontario CA L3R 1B2 L3R 1B2
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 |
| K020542 | DAYTRIPPER DIALYSATE WARMER | Stickman Industries, Inc. | 2002-09-27 |
| K993330 | THERMOCHEM-HT SYSTEM | Hemocleanse, Inc. | 1999-12-30 |
| K933619 | PD-PAK | General Medical Mfg. Co. | 1994-02-22 |
Legacy Summary#
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FDA Review#
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