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510(k) K023761

PLATELETWORKS, MODELS PW-A, PW-C by Helena Laboratories — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2003
Date Received
November 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

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