The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Multilumen Subclavian Jugular.
Device ID | K840355 |
510k Number | K840355 |
Device Name: | DESERET MULTILUMEN SUBCLAVIAN JUGULAR |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PARKE-DAVIS CO. 2337 PARKDALE AVE. Brookville, Ontario, CA K62 5ws |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-26 |
Decision Date | 1984-03-19 |