The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surflo Flex I.v. Catheter And Terumo Surflash I.v. Catheter.
Device ID | K991406 |
510k Number | K991406 |
Device Name: | TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Kristine Wagner |
Correspondent | Kristine Wagner TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-22 |
Decision Date | 1999-06-16 |
Summary: | summary |