The following data is part of a premarket notification filed by Hemocleanse, Inc. with the FDA for Thermochem-ht System.
Device ID | K993330 |
510k Number | K993330 |
Device Name: | THERMOCHEM-HT SYSTEM |
Classification | Warmer, Peritoneal Dialysate |
Applicant | HEMOCLEANSE, INC. 2700 KENT AVE. West Lafayette, IN 47906 |
Contact | Stephen R Ash |
Correspondent | Stephen R Ash HEMOCLEANSE, INC. 2700 KENT AVE. West Lafayette, IN 47906 |
Product Code | MLW |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-04 |
Decision Date | 1999-12-30 |
Summary: | summary |