The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Intra Cath-dsa Intravenous Cath Place..
Device ID | K823065 |
510k Number | K823065 |
Device Name: | INTRA CATH-DSA INTRAVENOUS CATH PLACE. |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | PARKE-DAVIS CO. UT |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-18 |
Decision Date | 1982-12-15 |