The following data is part of a premarket notification filed by Schoelly Technologies, Inc. with the FDA for Arthroscope,rigid Rod-lens Diagnostic Endoscope.
| Device ID | K943426 |
| 510k Number | K943426 |
| Device Name: | ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE |
| Classification | Arthroscope |
| Applicant | SCHOELLY TECHNOLOGIES, INC. TWO OAKWOOD BLVD. SUITE 160 Hollywood, FL 33020 |
| Contact | Kenneth J Durbin |
| Correspondent | Kenneth J Durbin SCHOELLY TECHNOLOGIES, INC. TWO OAKWOOD BLVD. SUITE 160 Hollywood, FL 33020 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1995-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B089B659660 | K943426 | 000 |
| B089B659250 | K943426 | 000 |
| B089B659220 | K943426 | 000 |
| B089B659210 | K943426 | 000 |
| B089B659200 | K943426 | 000 |
| B089B659100 | K943426 | 000 |