The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Force Fiber Orthotape Suture.
| Device ID | K150438 |
| 510k Number | K150438 |
| Device Name: | Force Fiber OrthoTape Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | TELEFLEX MEDICAL, INC. OEM 375 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva TELEFLEX MEDICAL, INC. OEM 375 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-19 |
| Decision Date | 2015-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818614021222 | K150438 | 000 |
| B048VAL2016WT1 | K150438 | 000 |
| B048VAL2020BBT1 | K150438 | 000 |
| B048VAL2020BT1 | K150438 | 000 |
| B048VAL2020WGT0 | K150438 | 000 |
| VAL2020WT1 | K150438 | 000 |
| B048VAL2024BT1 | K150438 | 000 |
| B048VAL2024WT1 | K150438 | 000 |
| B048VAL2030BT0 | K150438 | 000 |
| B048VAL2030WT0 | K150438 | 000 |
| 10818614020683 | K150438 | 000 |
| 10818614020690 | K150438 | 000 |
| 10818614020713 | K150438 | 000 |
| 10818614020720 | K150438 | 000 |
| 10818614020737 | K150438 | 000 |
| 10818614020744 | K150438 | 000 |
| 10818614020751 | K150438 | 000 |
| 10818614020768 | K150438 | 000 |
| B048VAL2016BT0 | K150438 | 000 |