The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo Surguard 3 Safety Hypodermic Needle.
| Device ID | K152362 |
| 510k Number | K152362 |
| Device Name: | Terumo SurGuard 3 Safety Hypodermic Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO (PHILIPPINES) CORPORATION 124 EAST MAIN AVENUE, LAGUNA TECHNOPARK Binan, PH |
| Contact | Phebe Varghese |
| Correspondent | Phebe Varghese TERUMO MEDICAL CORPORATION 265 DAVIDSON AVENUE, SUITE 320 Somerset, NJ 08873 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2015-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34806017510757 | K152362 | 000 |
| 54806017510744 | K152362 | 000 |
| 34806017510733 | K152362 | 000 |
| 34806017510726 | K152362 | 000 |
| 54806017510713 | K152362 | 000 |
| 54806017510706 | K152362 | 000 |
| 54806017509618 | K152362 | 000 |
| 34806017509584 | K152362 | 000 |