The following data is part of a premarket notification filed by Squibb Diagnostics with the FDA for Acces. Package For Use W/cardiogen-82 Generator.
| Device ID | K883609 |
| 510k Number | K883609 |
| Device Name: | ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR |
| Classification | Pump, Infusion |
| Applicant | SQUIBB DIAGNOSTICS P.O. BOX 191 New Brunswick, NJ 08903 |
| Contact | Leonard M Baum |
| Correspondent | Leonard M Baum SQUIBB DIAGNOSTICS P.O. BOX 191 New Brunswick, NJ 08903 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-22 |
| Decision Date | 1989-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50815112020038 | K883609 | 000 |