The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Panalok Wedge Absorable Suture Anchor System.
| Device ID | K952687 |
| 510k Number | K952687 |
| Device Name: | PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | John D Paulson |
| Correspondent | John D Paulson ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | MAI |
| Subsequent Product Code | HRX |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1996-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705000982 | K952687 | 000 |