The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for 'cottony' Ii Tape, Pledgets.
| Device ID | K153089 |
| 510k Number | K153089 |
| Device Name: | 'cottony' II TAPE, PLEDGETS |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Natalie Hichak |
| Correspondent | Natalie Hichak Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | GAT |
| Subsequent Product Code | DXZ |
| Subsequent Product Code | GAO |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAQ |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2016-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704673170 | K153089 | 000 |
| 34026704421962 | K153089 | 000 |
| 34026704426264 | K153089 | 000 |
| 34026704427254 | K153089 | 000 |
| 34026704633174 | K153089 | 000 |
| 34026704634003 | K153089 | 000 |
| 34026704638582 | K153089 | 000 |
| 34026704638612 | K153089 | 000 |
| 34026704638629 | K153089 | 000 |
| 34026704638636 | K153089 | 000 |
| 34026704638650 | K153089 | 000 |
| 34026704633167 | K153089 | 000 |
| 34026704673187 | K153089 | 000 |
| 34026704634089 | K153089 | 000 |