The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Dantec 13l40 St. Marks's Pudendal Electrode.
Device ID | K874758 |
510k Number | K874758 |
Device Name: | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE |
Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
Contact | Henrik Henriksen |
Correspondent | Henrik Henriksen DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
Product Code | FAP |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-18 |
Decision Date | 1988-04-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05704736005852 | K874758 | 000 |