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 |