The following data is part of a premarket notification filed by Biocor, Inc. with the FDA for Flu Admin/waste Disp Sys/protec Sta/admin/flush-n-.
| Device ID | K912861 |
| 510k Number | K912861 |
| Device Name: | FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N- |
| Classification | Set, Administration, Intravascular |
| Applicant | BIOCOR, INC. 102 N. COLLEGE P.O. BOX 539 Tyler, TX 75702 |
| Contact | Mickey Fowler |
| Correspondent | Mickey Fowler BIOCOR, INC. 102 N. COLLEGE P.O. BOX 539 Tyler, TX 75702 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-27 |
| Decision Date | 1991-09-24 |