The following data is part of a premarket notification filed by Medicor Corp. with the FDA for Insulscan Insulation Testing System.
| Device ID | K991424 |
| 510k Number | K991424 |
| Device Name: | INSULSCAN INSULATION TESTING SYSTEM |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | MEDICOR CORP. 150 FAIRWAY DR. SUITE 164 Vernon Hills, IL 60061 |
| Contact | Scott B Kerrigan |
| Correspondent | Scott B Kerrigan MEDICOR CORP. 150 FAIRWAY DR. SUITE 164 Vernon Hills, IL 60061 |
| Product Code | HFG |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-07-22 |
| Summary: | summary |