The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Flexible Endoscopic Scissors.
| Device ID | K010412 |
| 510k Number | K010412 |
| Device Name: | FLEXIBLE ENDOSCOPIC SCISSORS |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Contact | Michael Carroll |
| Correspondent | Michael Carroll TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-04-02 |
| Summary: | summary |