The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Endobutton Continuous Loop.
| Device ID | K980155 |
| 510k Number | K980155 |
| Device Name: | ENDOBUTTON CONTINUOUS LOOP |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Demetrios Tsakonas |
| Correspondent | Demetrios Tsakonas SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554028546 | K980155 | 000 |
| 03596010496997 | K980155 | 000 |
| 03596010496980 | K980155 | 000 |
| 03596010496973 | K980155 | 000 |
| 03596010388292 | K980155 | 000 |
| 03596010388285 | K980155 | 000 |
| 03596010388278 | K980155 | 000 |
| 03596010001214 | K980155 | 000 |
| 03596010000491 | K980155 | 000 |
| 03596010469588 | K980155 | 000 |
| 03596010469571 | K980155 | 000 |
| 03596010388339 | K980155 | 000 |
| 03596010388322 | K980155 | 000 |
| 03596010388315 | K980155 | 000 |
| 03596010497000 | K980155 | 000 |
| 03596010497017 | K980155 | 000 |
| 03596010497024 | K980155 | 000 |
| 00885554021738 | K980155 | 000 |
| 03596010597342 | K980155 | 000 |
| 03596010597335 | K980155 | 000 |
| 03596010597328 | K980155 | 000 |
| 03596010597311 | K980155 | 000 |
| 03596010597304 | K980155 | 000 |
| 03596010597298 | K980155 | 000 |
| 03596010597281 | K980155 | 000 |
| 03596010597274 | K980155 | 000 |
| 03596010597267 | K980155 | 000 |
| 03596010597250 | K980155 | 000 |
| 03596010497048 | K980155 | 000 |
| 03596010497031 | K980155 | 000 |
| 03596010388308 | K980155 | 000 |