The following data is part of a premarket notification filed by Canberra Industries, Inc. with the FDA for Fibrinogen Uptake Sys -various Models.
| Device ID | K834168 |
| 510k Number | K834168 |
| Device Name: | FIBRINOGEN UPTAKE SYS -VARIOUS MODELS |
| Classification | Snare, Ear |
| Applicant | CANBERRA INDUSTRIES, INC. 45 GRACEY AVENUE Meriden , CT 06450 - |
| Contact | Ron Simmons |
| Correspondent | Ron Simmons CANBERRA INDUSTRIES, INC. 45 GRACEY AVENUE Meriden , CT 06450 - |
| Product Code | JZD |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-04 |
| Decision Date | 1983-12-29 |