The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Hac Autology Centers Dispensing Kit For Fib.con..
| Device ID | K880963 |
| 510k Number | K880963 |
| Device Name: | HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON. |
| Classification | Syringe, Piston |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-06-24 |