The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Disscap 110 Dialyzer.
Device ID | K851380 |
510k Number | K851380 |
Device Name: | DISSCAP 110 DIALYZER |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
Contact | Douglas S Vlchek |
Correspondent | Douglas S Vlchek 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 | 1985-04-08 |
Decision Date | 1985-04-25 |