The following data is part of a premarket notification filed by Specialty Medical Products Co. with the FDA for Iv Start Kit Custom Smp # A-z.
Device ID | K922533 |
510k Number | K922533 |
Device Name: | IV START KIT CUSTOM SMP # A-Z |
Classification | I.v. Start Kit |
Applicant | SPECIALTY MEDICAL PRODUCTS CO. 1604 MERRILL DR. SUITE D Little Rock, AK 72212 |
Contact | John Lamb |
Correspondent | John Lamb SPECIALTY MEDICAL PRODUCTS CO. 1604 MERRILL DR. SUITE D Little Rock, AK 72212 |
Product Code | LRS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-28 |
Decision Date | 1993-03-23 |