The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek Physician Dispen. Patient Self-inject Kit.
| Device ID | K870518 |
| 510k Number | K870518 |
| Device Name: | SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT |
| Classification | Syringe, Piston |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Betty A Lock |
| Correspondent | Betty A Lock SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-05 |
| Decision Date | 1987-04-29 |