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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K990019
Device Name DRG MEDIUM SCREW SYSTEM
Applicant
Dolphin Medical Technologies, Inc.
5959 Cattlemen Ln.
Sarasota,  FL  34232
Applicant Contact MARK G URBANSKI
Correspondent
Dolphin Medical Technologies, Inc.
5959 Cattlemen Ln.
Sarasota,  FL  34232
Correspondent Contact MARK G URBANSKI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/04/1999
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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