The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Multiflo Adapter.
Device ID | K882798 |
510k Number | K882798 |
Device Name: | MULTIFLO ADAPTER |
Classification | Set, Administration, Intravascular |
Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | Charles J Welle |
Correspondent | Charles J Welle DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-06 |
Decision Date | 1988-07-18 |