The following data is part of a premarket notification filed by Schoelly Imaging, Inc. with the FDA for Flexiscope, Models 50mh And 50 Mhc.
| Device ID | K053412 |
| 510k Number | K053412 |
| Device Name: | FLEXISCOPE, MODELS 50MH AND 50 MHC |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | SCHOELLY IMAGING, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau SCHOELLY IMAGING, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-07 |
| Decision Date | 2006-02-23 |
| Summary: | summary |