The following data is part of a premarket notification filed by Pharmacia Hepar, Inc. with the FDA for Coamatic Factor Viii.
| Device ID | K943225 |
| 510k Number | K943225 |
| Device Name: | COAMATIC FACTOR VIII |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | PHARMACIA HEPAR, INC. 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Contact | Cynthia A Ipach |
| Correspondent | Cynthia A Ipach PHARMACIA HEPAR, INC. 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-06 |
| Decision Date | 1995-11-06 |