The following data is part of a premarket notification filed by Hemostatix Medical Technologies, Llc with the FDA for Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable Blades.
| Device ID | K183009 |
| 510k Number | K183009 |
| Device Name: | HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Hemostatix Medical Technologies, LLC 8400 Wolf Lake Drive, STE 109 Bartlett, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb Hemostatix Medical Technologies, LLC 8400 Wolf Lake Drive, STE 109 Bartlett, TN 38133 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-31 |
| Decision Date | 2018-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858736006151 | K183009 | 000 |
| 00850007350253 | K183009 | 000 |
| 00850007350291 | K183009 | 000 |
| 00850007350284 | K183009 | 000 |
| 00850007350307 | K183009 | 000 |
| 00858736006083 | K183009 | 000 |
| 00858736006090 | K183009 | 000 |
| 00858736006106 | K183009 | 000 |
| 00858736006113 | K183009 | 000 |
| 00858736006120 | K183009 | 000 |
| 00858736006144 | K183009 | 000 |
| 10850007350250 | K183009 | 000 |