The following data is part of a premarket notification filed by Slater Endoscopy, Llc with the FDA for Ensizor Endoscopic Scissors.
| Device ID | K150939 |
| 510k Number | K150939 |
| Device Name: | Ensizor Endoscopic Scissors |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | SLATER ENDOSCOPY, LLC 14000 NW 58TH COURT Miami Lakes, FL 33014 |
| Contact | John Starkey |
| Correspondent | Craig Pagan C2C DEVELOPMENT, LLC 1135 W NASA BLVD, SUITE 500 Melbourne, FL 32901 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-07 |
| Decision Date | 2015-06-08 |
| Summary: | summary |