The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Modification To Terumo Syringe With/without Needle.
| Device ID | K063613 |
| 510k Number | K063613 |
| Device Name: | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE |
| Classification | Syringe, Piston |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 950 Elkton Blvd. 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 | 2006-12-05 |
| Decision Date | 2006-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54806017511468 | K063613 | 000 |
| 54806017511451 | K063613 | 000 |
| 54806017511444 | K063613 | 000 |
| 54806017511437 | K063613 | 000 |
| 54806017511420 | K063613 | 000 |
| 54806017511413 | K063613 | 000 |
| 54806017509434 | K063613 | 000 |