The following data is part of a premarket notification filed by Hemostatix Medical Technologies, Llc with the FDA for Model P8400 Hemostatix Thermal Scalpel System.
| Device ID | K091107 |
| 510k Number | K091107 |
| Device Name: | MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HEMOSTATIX MEDICAL TECHNOLOGIES, LLC 8400 WOLF LAKE DR., STE. 109 Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-16 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858736006168 | K091107 | 000 |
| 00858736006021 | K091107 | 000 |
| 00858736006014 | K091107 | 000 |
| 00858736006007 | K091107 | 000 |
| 10850007350236 | K091107 | 000 |
| 00850007350222 | K091107 | 000 |
| 00850007350208 | K091107 | 000 |