The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Cord-assure Umbilical Blood Gas Kit.
| Device ID | K872244 |
| 510k Number | K872244 |
| Device Name: | CORD-ASSURE UMBILICAL BLOOD GAS KIT |
| Classification | Arterial Blood Sampling Kit |
| Applicant | LAKE MEDICAL PRODUCTS, INC. 11866 ADIE RD. Maryland Heights, MO 63043 |
| Contact | Eli Schachet |
| Correspondent | Eli Schachet LAKE MEDICAL PRODUCTS, INC. 11866 ADIE RD. Maryland Heights, MO 63043 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-11 |
| Decision Date | 1987-07-21 |