The following data is part of a premarket notification filed by Faulding Medical Device Co. with the FDA for Safe-connect Vial Dispensing Spike.
| Device ID | K970789 |
| 510k Number | K970789 |
| Device Name: | SAFE-CONNECT VIAL DISPENSING SPIKE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
| Contact | Bruce Craney |
| Correspondent | Bruce Craney FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-05-01 |