The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Tecnadyne Surgi-squeeze Infusion Pump.
| Device ID | K910926 |
| 510k Number | K910926 |
| Device Name: | TECNADYNE SURGI-SQUEEZE INFUSION PUMP |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | TECNADYNE SCIENTIFIC, INC. 740 C FOURTEENTH ST. Vero Beach, FL 32960 |
| Contact | John R Garrett |
| Correspondent | John R Garrett TECNADYNE SCIENTIFIC, INC. 740 C FOURTEENTH ST. Vero Beach, FL 32960 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-05 |
| Decision Date | 1991-08-02 |