Name: Predicase
Price: 199 USD

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.
Product code	HTN
Device class	Class II
Decision date	Nov 23, 1998
Decision	Substantially Equivalent
Regulation	888.3030

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View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.