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Trade Name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
Classification Name | transilluminator, fiber optic |
Generic Name | transilluminator, fiber optic |
Regulation Number | 874.4350 |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
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HDE Number | H020008 |
Supplement Number | S021 |
Date Received | 03/14/2012 |
Decision Date | 07/26/2013 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for use of an alternate gamma irradiation terminal sterilization supplier, as well as modifications to the details of the irradiation sterilization processing, auditing and release testing. |