The following data is part of a premarket notification filed by Vilex, Inc. with the FDA for Met-head Model# Mhdd-xx:cc Diameter, Cc Cannulation.
| Device ID | K070052 |
| 510k Number | K070052 |
| Device Name: | MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | VILEX, INC. 345 OLD CURRY HOLLOW RD. Pittsburgh, PA 15236 |
| Contact | Abraham Lavi |
| Correspondent | Abraham Lavi VILEX, INC. 345 OLD CURRY HOLLOW RD. Pittsburgh, PA 15236 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-04 |
| Decision Date | 2007-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841731106469 | K070052 | 000 |
| 00841731106339 | K070052 | 000 |
| 00841731106346 | K070052 | 000 |
| 00841731106353 | K070052 | 000 |
| 00841731106360 | K070052 | 000 |
| 00841731106421 | K070052 | 000 |
| 00841731106438 | K070052 | 000 |
| 00841731106445 | K070052 | 000 |
| 00841731106452 | K070052 | 000 |
| 00841731106322 | K070052 | 000 |