The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed Trocars, Model B5lt And Cb5lt.
| Device ID | K100080 |
| 510k Number | K100080 |
| Device Name: | REPROCESSED TROCARS, MODEL B5LT AND CB5LT |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moira Barton-varty |
| Correspondent | Moira Barton-varty ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-12 |
| Decision Date | 2010-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825014422 | K100080 | 000 |
| 30885825014194 | K100080 | 000 |