The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Panalok Loop Anchor.
| Device ID | K040827 |
| 510k Number | K040827 |
| Device Name: | PANALOK LOOP ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT DR. Norwood, MA 02062 |
| Contact | Allyson Barford |
| Correspondent | Allyson Barford DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 249 VANDERBILT DR. Norwood, MA 02062 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-30 |
| Decision Date | 2004-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705008582 | K040827 | 000 |