The following data is part of a premarket notification filed by Grand Medical Products with the FDA for Iv Start Kit.
Device ID | K963722 |
510k Number | K963722 |
Device Name: | IV START KIT |
Classification | I.v. Start Kit |
Applicant | GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
Contact | Harvey Weiss |
Correspondent | Harvey Weiss GRAND MEDICAL PRODUCTS 1300 REMINGTON ROAD, SUITE K Schaumburg, IL 60173 |
Product Code | LRS |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-16 |
Decision Date | 1996-11-27 |