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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K982354
Device Name SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
Applicant
Special Devices, Inc.
12493 Old Rough And Ready Hwy.
Grass Valley,  CA  95945
Applicant Contact JOSEPH J SPRANZA
Correspondent
Special Devices, Inc.
12493 Old Rough And Ready Hwy.
Grass Valley,  CA  95945
Correspondent Contact JOSEPH J SPRANZA
Regulation Number888.3030
Classification Product Code
HTN  
Date Received07/06/1998
Decision Date 11/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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