The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Tecnadyne Endoscopic Instrument Holder.
| Device ID | K940891 |
| 510k Number | K940891 |
| Device Name: | TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TECNADYNE SCIENTIFIC, INC. 546 1ST ST. Vero Beach, FL 32962 |
| Contact | John R Garrett |
| Correspondent | John R Garrett TECNADYNE SCIENTIFIC, INC. 546 1ST ST. Vero Beach, FL 32962 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-25 |
| Decision Date | 1994-04-26 |