The following data is part of a premarket notification filed by Instratek, Inc. with the FDA for Endoscopic Mortons Neuroma Instruments.
| Device ID | K940230 |
| 510k Number | K940230 |
| Device Name: | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS |
| Classification | Arthroscope |
| Applicant | INSTRATEK, INC. 11210 STEEPLECREST SUITE 130 Houston, TX 77065 |
| Contact | Perry C Forrester |
| Correspondent | Perry C Forrester INSTRATEK, INC. 11210 STEEPLECREST SUITE 130 Houston, TX 77065 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-14 |
| Decision Date | 1994-12-12 |