The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Catheter, Multiple Lumen.
Device ID | K820446 |
510k Number | K820446 |
Device Name: | CATHETER, MULTIPLE LUMEN |
Classification | Catheter, Multiple Lumen |
Applicant | DLP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GBP |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-18 |
Decision Date | 1982-03-11 |