The following data is part of a premarket notification filed by Technadyne Scientific, Inc. with the FDA for Tecnadyne T-cuff.
| Device ID | K942303 |
| 510k Number | K942303 |
| Device Name: | TECNADYNE T-CUFF |
| Classification | Tourniquet, Pneumatic |
| Applicant | TECHNADYNE SCIENTIFIC, INC. 546 1ST ST. Vero Beach, FL 32962 |
| Contact | John R Garrett |
| Correspondent | John R Garrett TECHNADYNE SCIENTIFIC, INC. 546 1ST ST. Vero Beach, FL 32962 |
| Product Code | KCY |
| CFR Regulation Number | 878.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-13 |
| Decision Date | 1994-07-20 |