The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Monocrystant Ph/les Catheter, Modification.
Device ID | K914793 |
510k Number | K914793 |
Device Name: | MONOCRYSTANT PH/LES CATHETER, MODIFICATION |
Classification | Monitor, Esophageal Motility, And Tube |
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 | KLA |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-26 |
Decision Date | 1993-12-13 |