The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Sterile, Dispos. Spike Protector-5c4138.
| Device ID | K823777 |
| 510k Number | K823777 |
| Device Name: | STERILE, DISPOS. SPIKE PROTECTOR-5C4138 |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-15 |
| Decision Date | 1983-01-07 |