The following data is part of a premarket notification filed by Dolphin Medical Technologies, Inc. with the FDA for Drg Large Screw System.
Device ID | K973810 |
510k Number | K973810 |
Device Name: | DRG LARGE 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 For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-07 |
Decision Date | 1998-01-05 |
Summary: | summary |