The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Dri-lyte.
Device ID | K780353 |
510k Number | K780353 |
Device Name: | DRI-LYTE |
Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPO |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-03 |
Decision Date | 1978-04-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DRI-LYTE 73132417 1083148 Dead/Cancelled |
Mallinckrodt, Inc. 1977-06-30 |