The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surguard Safety Syringe.
Device ID | K024249 |
510k Number | K024249 |
Device Name: | TERUMO SURGUARD SAFETY SYRINGE |
Classification | Syringe, Antistick |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Barbara Smith |
Correspondent | Barbara Smith TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-23 |
Decision Date | 2003-02-21 |
Summary: | summary |