The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Protoe Endosorb Small Hammer Toe Pin.
| Device ID | K100414 |
| 510k Number | K100414 |
| Device Name: | PROTOE ENDOSORB SMALL HAMMER TOE PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | MERETE MEDICAL GMBH ALT LANKWITZ 102 Berlin, DE 12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH ALT LANKWITZ 102 Berlin, DE 12247 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-07-02 |
| Summary: | summary |