The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Stago Factor Xi-deficient Plasma.
| Device ID | K933444 |
| 510k Number | K933444 |
| Device Name: | STAGO FACTOR XI-DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Andrew Loc B. Le |
| Correspondent | Andrew Loc B. Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-14 |
| Decision Date | 1993-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450007234 | K933444 | 000 |