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 |