The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Adsorba 150c.
| Device ID | K873643 |
| 510k Number | K873643 |
| Device Name: | GAMBRO ADSORBA 150C |
| Classification | Apparatus, Hemoperfusion, Sorbent |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey Shideman,phd |
| Correspondent | Jeffrey Shideman,phd GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | FLD |
| CFR Regulation Number | 876.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-09 |
| Decision Date | 1987-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414015481 | K873643 | 000 |