The following data is part of a premarket notification filed by Dip, Inc. with the FDA for Set For Aseptic Decanting Of A Flex I.v.
Device ID | K812852 |
510k Number | K812852 |
Device Name: | SET FOR ASEPTIC DECANTING OF A FLEX I.V |
Classification | Container, I.v. |
Applicant | DIP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-13 |
Decision Date | 1981-11-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994900443 | K812852 | 000 |
20613994900429 | K812852 | 000 |
20613994887553 | K812852 | 000 |
20613994887546 | K812852 | 000 |