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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 K951656
Device Name NEXMED CANCELLOUS BONE SCREWS
Applicant
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211
Applicant Contact REBECCA H WAHL
Correspondent
Nexmed, Inc.
42-160 State St.
Palm Desert,  CA  92211
Correspondent Contact REBECCA H WAHL
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/10/1995
Decision Date 07/18/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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