The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Sentry Insertion Tray.
| Device ID | K942827 |
| 510k Number | K942827 |
| Device Name: | SENTRY INSERTION TRAY |
| Classification | Catheter, Umbilical Artery |
| Applicant | SENTRY MEDICAL PRODUCTS, INC. 331 S. EISENHOWER LN. Lombard, IL 60148 |
| Contact | James G Stokes |
| Correspondent | James G Stokes SENTRY MEDICAL PRODUCTS, INC. 331 S. EISENHOWER LN. Lombard, IL 60148 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-14 |
| Decision Date | 1994-11-02 |