The following data is part of a premarket notification filed by Slater Endoscopy, Llc with the FDA for Ensizor Endoscopic Scissors.
| Device ID | K141058 |
| 510k Number | K141058 |
| Device Name: | ENSIZOR ENDOSCOPIC SCISSORS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | SLATER ENDOSCOPY, LLC 1135 W NASA BLVD. SUITE 500 Melbourne, FL 32901 |
| Contact | Craig Pagan |
| Correspondent | Craig Pagan SLATER ENDOSCOPY, 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 | 2014-04-24 |
| Decision Date | 2014-08-01 |
| Summary: | summary |