The following data is part of a premarket notification filed by Fiber Imaging Technologies, Inc. with the FDA for Schoelly Rigid Endoscopes.
| Device ID | K992437 |
| 510k Number | K992437 |
| Device Name: | SCHOELLY RIGID ENDOSCOPES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Contact | Joseph Ress |
| Correspondent | Joseph Ress FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. Newton, MA 02468 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-22 |
| Decision Date | 1999-09-14 |