The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek(r) External Fill Port.
| Device ID | K894495 |
| 510k Number | K894495 |
| Device Name: | SURGITEK(R) EXTERNAL FILL PORT |
| Classification | Expander, Skin, Inflatable |
| 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 | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1990-01-17 |