The following data is part of a premarket notification filed by Flynt Amtex, Inc. with the FDA for Tex-care Sterile Stockinette.
| Device ID | K955749 |
| 510k Number | K955749 |
| Device Name: | TEX-CARE STERILE STOCKINETTE |
| Classification | Drape, Surgical |
| Applicant | FLYNT AMTEX, INC. 673 GILMER ST. Burlington, NC 27217 |
| Contact | John A Kranaskas |
| Correspondent | John A Kranaskas FLYNT AMTEX, INC. 673 GILMER ST. Burlington, NC 27217 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-19 |
| Decision Date | 1996-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00632195002028 | K955749 | 000 |
| 00632195000390 | K955749 | 000 |
| 00632195000406 | K955749 | 000 |
| 00632195000413 | K955749 | 000 |
| 00632195000420 | K955749 | 000 |
| 00632195000437 | K955749 | 000 |
| 00632195000444 | K955749 | 000 |
| 00632195000451 | K955749 | 000 |
| 00632195000468 | K955749 | 000 |
| 00632195000383 | K955749 | 000 |
| 00632195000376 | K955749 | 000 |
| 00632195000291 | K955749 | 000 |
| 00632195000307 | K955749 | 000 |
| 00632195000314 | K955749 | 000 |
| 00632195000321 | K955749 | 000 |
| 00632195000338 | K955749 | 000 |
| 00632195000345 | K955749 | 000 |
| 00632195000352 | K955749 | 000 |
| 00632195000369 | K955749 | 000 |
| 00632195000475 | K955749 | 000 |
| 00632195000482 | K955749 | 000 |
| 00632195001793 | K955749 | 000 |
| 00632195001809 | K955749 | 000 |
| 00632195001816 | K955749 | 000 |
| 00632195001823 | K955749 | 000 |
| 00632195001830 | K955749 | 000 |
| 00632195001847 | K955749 | 000 |
| 00632195001854 | K955749 | 000 |
| 00632195002011 | K955749 | 000 |
| 00632195001786 | K955749 | 000 |
| 00632195001779 | K955749 | 000 |
| 00632195001687 | K955749 | 000 |
| 00632195001700 | K955749 | 000 |
| 00632195001717 | K955749 | 000 |
| 00632195001724 | K955749 | 000 |
| 00632195001731 | K955749 | 000 |
| 00632195001748 | K955749 | 000 |
| 00632195001755 | K955749 | 000 |
| 00632195001762 | K955749 | 000 |
| 00632195000284 | K955749 | 000 |