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510(k) K925608

Device
SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
Applicant
SCIMED LIFE SYSTEMS, INC.
510(k) number
K925608
Product code
MFY  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1993-06-16
Date received
1992-11-05
Regulation
870.4075
Classification name
Endothelial Cell Harvesting Kit
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MERCEDES P BAYANI
Address
6655 Wedgwood Rd. Maple Grove MN US 55369 55369

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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