The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Carapace Portable Cast Saw, Swiss-ex Cast Cutter.
| Device ID | K901677 |
| 510k Number | K901677 |
| Device Name: | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER |
| Classification | Instrument, Cast Removal, Ac-powered |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | LGH |
| CFR Regulation Number | 888.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-10 |
| Decision Date | 1990-04-23 |