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510(k) K913817

MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION by Synectics-Dantec — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
August 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ph, Stomach
Device Class
Class I
Regulation Number
876.1400
Review Panel
GU
Submission Type

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