The following data is part of a premarket notification filed by Electro Fiberoptics Corp. with the FDA for Arthroscope.
| Device ID | K943628 |
| 510k Number | K943628 |
| Device Name: | ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | ELECTRO FIBEROPTICS CORP. 45 BARTLETT ST. Marlborough, MA 01752 |
| Contact | Kenneth J Durbin |
| Correspondent | Kenneth J Durbin ELECTRO FIBEROPTICS CORP. 45 BARTLETT ST. Marlborough, MA 01752 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1994-11-22 |