The following data is part of a premarket notification filed by Imed Corp. with the FDA for Primary Admin Set W/univ Sp-man Below/abv Pump Ch.
Device ID | K931173 |
510k Number | K931173 |
Device Name: | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH |
Classification | Set, Administration, Intravascular |
Applicant | IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
Contact | Ahmad Sajadi |
Correspondent | Ahmad Sajadi IMED CORP. 9775 BUSINESSPARK AVE. San Diego, CA 92131 -1699 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-08 |
Decision Date | 1994-04-15 |