The following data is part of a premarket notification filed by Tecnadyne Scientific, Inc. with the FDA for Tecnadyne 20/20 Fog Inhibitor Kit.
| Device ID | K940431 |
| 510k Number | K940431 |
| Device Name: | TECNADYNE 20/20 FOG INHIBITOR KIT |
| 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 | 1994-01-31 |
| Decision Date | 1994-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651501098 | K940431 | 000 |