The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Mod. Dm-357 Bicarbonate Retrofit Kit.
Device ID | K800772 |
510k Number | K800772 |
Device Name: | MOD. DM-357 BICARBONATE RETROFIT KIT |
Classification | Subsystem, Proportioning |
Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKR |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-07 |
Decision Date | 1980-05-14 |