The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Sterile Cotton Balls.
| Device ID | K931626 |
| 510k Number | K931626 |
| Device Name: | CARAPACE STERILE COTTON BALLS |
| Classification | Fiber, Medical, Absorbent |
| 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 | FRL |
| CFR Regulation Number | 880.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1993-12-02 |