The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Bsm 21 Blood Safety Module.
| Device ID | K852135 |
| 510k Number | K852135 |
| Device Name: | BSM 21 BLOOD SAFETY MODULE |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Contact | Fressinet |
| Correspondent | Fressinet HOSPAL MEDICAL CORP. 25 KIMBERLY RD. P.O. BOX 857 East Brunswick, NJ 08816 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-16 |
| Decision Date | 1985-06-12 |