The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Disscap.
Device ID | K781142 |
510k Number | K781142 |
Device Name: | DISSCAP |
Classification | Dialyzer, Capillary, Hollow Fiber |
Applicant | HOSPAL MEDICAL CORP. CO |
Product Code | FJI |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-10 |
Decision Date | 1978-09-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DISSCAP 73215564 1156246 Dead/Cancelled |
Hospal Ltd. (Hospal AG) (Hospal S.A.) 1979-05-14 |