The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Labor And Delivery Sets.
| Device ID | K931722 |
| 510k Number | K931722 |
| Device Name: | CARAPACE LABOR AND DELIVERY SETS |
| Classification | Labor And Delivery Kit |
| Applicant | CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
| Contact | Jerry Myers |
| Correspondent | Jerry Myers CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
| Product Code | MLS |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-07 |
| Decision Date | 1994-03-23 |