The following data is part of a premarket notification filed by Precision Biologicals, Inc. with the FDA for Coagulation Control Plasma (normal & Abnormal).
| Device ID | K884854 |
| 510k Number | K884854 |
| Device Name: | COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL) |
| Classification | Plasma, Coagulation Control |
| Applicant | PRECISION BIOLOGICALS, INC. 11A PETTIPAS DR. Dartmouth, CA Ns B3b 1k1 |
| Contact | Tony Bebbington |
| Correspondent | Tony Bebbington PRECISION BIOLOGICALS, INC. 11A PETTIPAS DR. Dartmouth, CA Ns B3b 1k1 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1989-01-30 |