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 |