The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Swisstek 2000(tm) Cast Removal System.
| Device ID | K932653 |
| 510k Number | K932653 |
| Device Name: | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM |
| Classification | Instrument, Cast Removal, Ac-powered |
| 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 | LGH |
| CFR Regulation Number | 888.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1994-01-28 |