The following data is part of a premarket notification filed by Medegen Medical Manufacturing Services with the FDA for Drug Access Spike.
| Device ID | K051930 |
| 510k Number | K051930 |
| Device Name: | DRUG ACCESS SPIKE |
| Classification | Syringe, Piston |
| Applicant | MEDEGEN MEDICAL MANUFACTURING SERVICES 15 CHEROKEE Trabuco Canyon, CA 92679 |
| Contact | Salvadore F Palomares |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-07-13 |
| Decision Date | 2005-08-16 |
| Summary: | summary |