The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Gfs Ii Standard, Gfs Ii Large, Gfs Mimi.
| Device ID | K133757 |
| 510k Number | K133757 |
| Device Name: | GFS II STANDARD, GFS II LARGE, GFS MIMI |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PARCUS MEDICAL, LLC 6423 PARKLAND DRIVE Sarasota, FL 34243 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts PARCUS MEDICAL, LLC 6423 PARKLAND DRIVE Sarasota, FL 34243 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-11 |
| Decision Date | 2014-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342021692 | K133757 | 000 |
| 00816342021821 | K133757 | 000 |
| 00816342021814 | K133757 | 000 |
| 00816342021807 | K133757 | 000 |
| 00816342021791 | K133757 | 000 |
| 00816342021784 | K133757 | 000 |
| 00816342021777 | K133757 | 000 |
| 00816342021760 | K133757 | 000 |
| 00816342021753 | K133757 | 000 |
| 00816342021746 | K133757 | 000 |
| 00816342021739 | K133757 | 000 |
| 00816342021722 | K133757 | 000 |
| 00816342021715 | K133757 | 000 |
| 00816342021838 | K133757 | 000 |
| 00816342021845 | K133757 | 000 |
| 00816342021968 | K133757 | 000 |
| 00816342021951 | K133757 | 000 |
| 00816342021944 | K133757 | 000 |
| 00816342021937 | K133757 | 000 |
| 00816342021920 | K133757 | 000 |
| 00816342021913 | K133757 | 000 |
| 00816342021906 | K133757 | 000 |
| 00816342021890 | K133757 | 000 |
| 00816342021883 | K133757 | 000 |
| 00816342021876 | K133757 | 000 |
| 00816342021869 | K133757 | 000 |
| 00816342021852 | K133757 | 000 |
| 00816342021708 | K133757 | 000 |