The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surflo(r) Injection Plug.
| Device ID | K891146 |
| 510k Number | K891146 |
| Device Name: | TERUMO SURFLO(R) INJECTION PLUG |
| Classification | Set, Administration, Intravascular |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | George S Momoda |
| Correspondent | George S Momoda TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-06-23 |