The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Tetrafluoroethylene (tfe) Polymer Pledget.
| Device ID | K953289 |
| 510k Number | K953289 |
| Device Name: | TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
| Contact | Lynne A Newquist |
| Correspondent | Lynne A Newquist DAVIS & GECK, INC. ONE CASPER ST. Danbury, CT 06810 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-14 |
| Decision Date | 1995-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521103174 | K953289 | 000 |
| 20884521104645 | K953289 | 000 |
| 20884521104638 | K953289 | 000 |
| 20884521104614 | K953289 | 000 |
| 20884521103181 | K953289 | 000 |