The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo U-100 Insulin Syring.
Device ID | K001474 |
510k Number | K001474 |
Device Name: | TERUMO U-100 INSULIN SYRING |
Classification | Syringe, Piston |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-11 |
Decision Date | 2000-06-09 |