The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Surguard 2 Safety Needle.
| Device ID | K031453 |
| 510k Number | K031453 |
| Device Name: | TERUMO SURGUARD 2 SAFETY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Barbara Smith |
| Correspondent | Barbara Smith TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-07 |
| Decision Date | 2003-07-08 |
| Summary: | summary |