FDA 510(k) Application Details - K961346

Device Classification Name	Electrode, Ph, Stomach   More FDA Info for this Device
510(K) Number	K961346
Device Name	Electrode, Ph, Stomach
Applicant	SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM SWEDEN S-116 28 SE Other 510(k) Applications for this Company
Contact	ANN PETTERSSON Other 510(k) Applications for this Contact
Regulation Number	876.1400   More FDA Info for this Regulation Number
Classification Product Code	FFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/1996
Decision Date	01/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review