The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Syringe With/without Needle.
| Device ID | K052034 |
| 510k Number | K052034 |
| Device Name: | TERUMO SYRINGE WITH/WITHOUT NEEDLE |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-28 |
| Decision Date | 2005-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54806017512397 | K052034 | 000 |
| 54806017511093 | K052034 | 000 |
| 54806017511086 | K052034 | 000 |
| 54806017511079 | K052034 | 000 |
| 54806017511062 | K052034 | 000 |
| 54806017511055 | K052034 | 000 |
| 54806017511048 | K052034 | 000 |