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510(k) K071126

CRYOSEAL FS APPLICATOR SYSTEM by Thermogenesis Corp. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2007
Date Received
April 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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