The following data is part of a premarket notification filed by Dolphin Medical Technologies, Inc. with the FDA for Drg Medium Screw System.
| Device ID | K990019 |
| 510k Number | K990019 |
| Device Name: | DRG MEDIUM SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | DOLPHIN MEDICAL TECHNOLOGIES, INC. 5959 CATTLEMEN LN. Sarasota, FL 34232 |
| Contact | Mark G Urbanski |
| Correspondent | Mark G Urbanski DOLPHIN MEDICAL TECHNOLOGIES, INC. 5959 CATTLEMEN LN. Sarasota, FL 34232 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-04 |
| Decision Date | 1999-03-15 |
| Summary: | summary |