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510(k) K880876

C-STAT/1000 by Sonne Medical, Inc. — Product Code LHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

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