The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Disscap 080.
Device ID | K822851 |
510k Number | K822851 |
Device Name: | DISSCAP 080 |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-24 |
Decision Date | 1982-10-04 |