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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K873005
Device Name TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
Applicant
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Applicant Contact CHARLES M RAGGIO
Correspondent
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Correspondent Contact CHARLES M RAGGIO
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/04/1987
Decision Date 09/01/1987
Decision Substantially Equivalent (SESE)
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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