The following data is part of a premarket notification filed by Prince Medical, Inc. with the FDA for Prince Medical Cement Plug.
| Device ID | K981855 |
| 510k Number | K981855 |
| Device Name: | PRINCE MEDICAL CEMENT PLUG |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | PRINCE MEDICAL, INC. 126 S.W. 140TH TERR. Newberry, FL 32669 |
| Contact | Michael Prince |
| Correspondent | Michael Prince PRINCE MEDICAL, INC. 126 S.W. 140TH TERR. Newberry, FL 32669 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-26 |
| Decision Date | 1998-08-10 |
| Summary: | summary |