The following data is part of a premarket notification filed by Al Pacheco And Associates with the FDA for Endotool Subq.
| Device ID | K180366 |
| 510k Number | K180366 |
| Device Name: | EndoTool SubQ |
| Classification | Calculator, Drug Dose |
| Applicant | Al Pacheco And Associates 2643 Galicia Way Carlsbad, CA 92009 |
| Contact | Al Pacheco |
| Correspondent | Al Pacheco Certified Compliance Solutions 11665 Avena Place Suite 203 San Diego, CA 92128 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003340608 | K180366 | 000 |