The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Microperforation Instrument.
| Device ID | K001507 |
| 510k Number | K001507 |
| Device Name: | MICROPERFORATION INSTRUMENT |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Nicholas Condakes |
| Correspondent | Nicholas Condakes SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2000-06-14 |