The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Kit, Prep, Inspiron Iv.
Device ID | K760313 |
510k Number | K760313 |
Device Name: | KIT, PREP, INSPIRON IV |
Classification | Infusor, Pressure, For I.v. Bags |
Applicant | INSPIRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KZD |
CFR Regulation Number | 880.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-26 |
Decision Date | 1976-08-04 |