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 |