The following data is part of a premarket notification filed by Impact Case Technologies, Inc. with the FDA for Freedom Traveller.
| Device ID | K964825 |
| 510k Number | K964825 |
| Device Name: | FREEDOM TRAVELLER |
| Classification | Warmer, Peritoneal Dialysate |
| Applicant | IMPACT CASE TECHNOLOGIES, INC. 20 STEELCASE RD., WEST, UNITS 6 & 7 Markham, Ontario, CA L3r 1b2 |
| Contact | Angela Hamlen |
| Correspondent | Angela Hamlen IMPACT CASE TECHNOLOGIES, INC. 20 STEELCASE RD., WEST, UNITS 6 & 7 Markham, Ontario, CA L3r 1b2 |
| Product Code | MLW |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-02 |
| Decision Date | 1997-05-19 |