The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Suture Removal Trays.
| Device ID | K931819 |
| 510k Number | K931819 |
| Device Name: | CARAPACE SUTURE REMOVAL TRAYS |
| Classification | Vibrator, Therapeutic |
| Applicant | CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
| Contact | Jerry W Myers |
| Correspondent | Jerry W Myers CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1994-01-26 |