The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo(r) Needle.
| Device ID | K121607 |
| 510k Number | K121607 |
| Device Name: | TERUMO(R) NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO (PHILIPPINES) CORPORATION 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 | 2012-06-01 |
| Decision Date | 2012-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54806017512045 | K121607 | 000 |
| 74806017511929 | K121607 | 000 |
| 54806017511918 | K121607 | 000 |
| 54806017511901 | K121607 | 000 |
| 54806017511895 | K121607 | 000 |
| 54806017511888 | K121607 | 000 |
| 74806017511875 | K121607 | 000 |
| 54806017511864 | K121607 | 000 |
| 54806017511857 | K121607 | 000 |
| 74806017511844 | K121607 | 000 |
| 74806017511936 | K121607 | 000 |
| 74806017511943 | K121607 | 000 |
| 54806017512038 | K121607 | 000 |
| 54806017512021 | K121607 | 000 |
| 74806017512018 | K121607 | 000 |
| 74806017512001 | K121607 | 000 |
| 74806017511998 | K121607 | 000 |
| 74806017511981 | K121607 | 000 |
| 74806017511974 | K121607 | 000 |
| 74806017511967 | K121607 | 000 |
| 54806017511956 | K121607 | 000 |
| 74806017511837 | K121607 | 000 |