The following data is part of a premarket notification filed by Fiber Imaging Technologies, Inc. with the FDA for Flexiscope Ii Arthroscopes And Accessories.
| Device ID | K992040 |
| 510k Number | K992040 |
| Device Name: | FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-17 |
| Decision Date | 1999-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851925007113 | K992040 | 000 |
| 00851925007106 | K992040 | 000 |
| 00851925007090 | K992040 | 000 |
| 00851925007083 | K992040 | 000 |
| 00851925007076 | K992040 | 000 |
| 00851925007069 | K992040 | 000 |