Substantially Equivalent 510(k) Device Information
Applicant: SCIMEDX Corp., Denville, NJ
510(k) number: BK960070
Product: Olympus PK-TP System Control Set
Date: 6/19/97
Summary of Safety and Effectiveness
PREMARKET NOTIFICATION
510(k) STATEMENT
(As Required by 21 CFR 807.93)
Olympus PK-TP Control Set
I certify that, in my capacity as President of Fujirebio America Inc., I will make available all information included in this Premarket Notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
-- signature --
Aki Shimauchi, President and Chief Executive Officer
Date: ___9/3/96___
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