The following data is part of a premarket notification filed by Mcgan Technology, Llc with the FDA for Micromed Pd-8k Insulation Defect Detector.
| Device ID | K101606 |
| 510k Number | K101606 |
| Device Name: | MICROMED PD-8K INSULATION DEFECT DETECTOR |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | MCGAN TECHNOLOGY, LLC 410 RIDGE ROAD Middletown, CT 06457 |
| Contact | Jack Ganis |
| Correspondent | Jack Ganis MCGAN TECHNOLOGY, LLC 410 RIDGE ROAD Middletown, CT 06457 |
| Product Code | HFG |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-10-01 |
| Summary: | summary |