The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fingershield Finger Guard, Model Ar-7199-xx.
| Device ID | K052387 |
| 510k Number | K052387 |
| Device Name: | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX |
| Classification | Finger Cot |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | LZB |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-31 |
| Decision Date | 2005-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888867041254 | K052387 | 000 |
| 00888867041257 | K052387 | 000 |