The following data is part of a premarket notification filed by Martech Medical Products, Inc. with the FDA for Neoline(tm).
| Device ID | K914778 |
| 510k Number | K914778 |
| Device Name: | NEOLINE(TM) |
| Classification | Arterial Blood Sampling Kit |
| Applicant | MARTECH MEDICAL PRODUCTS, INC. 43223 BUSINESS PARK DR. Temecula, CA 92590 |
| Contact | Michael D Martell |
| Correspondent | Michael D Martell MARTECH MEDICAL PRODUCTS, INC. 43223 BUSINESS PARK DR. Temecula, CA 92590 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-23 |
| Decision Date | 1992-09-16 |