The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Monocrystant Ph-reference Catheter, Modification.
Device ID | K913817 |
510k Number | K913817 |
Device Name: | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION |
Classification | Electrode, Ph, Stomach |
Applicant | SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden, SE S-116 28 |
Contact | Anna Pettersson |
Correspondent | Anna Pettersson SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden, SE S-116 28 |
Product Code | FFT |
CFR Regulation Number | 876.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-26 |
Decision Date | 1992-06-11 |