The following data is part of a premarket notification filed by Changzhou Dean Medical Instrument Co, Ltd with the FDA for Locking Compression Bone Plates And Screw System.
| Device ID | K133525 |
| 510k Number | K133525 |
| Device Name: | LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-03-04 |
| Summary: | summary |