The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Disscap 80e, 110e, 140e, 160e.
Device ID | K863592 |
510k Number | K863592 |
Device Name: | DISSCAP 80E, 110E, 140E, 160E |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
Contact | Catherina Madormo |
Correspondent | Catherina Madormo HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
Product Code | FJI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-15 |
Decision Date | 1986-09-25 |