The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Vial Syringe Pumps, Se200, Se200b & Se400.
| Device ID | K852073 |
| 510k Number | K852073 |
| Device Name: | VIAL SYRINGE PUMPS, SE200, SE200B & SE400 |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-13 |
| Decision Date | 1985-06-07 |