The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo Surguard3 Safety Needle & Hypodermic Syringe With Safety Needle.
| Device ID | K122249 |
| 510k Number | K122249 |
| Device Name: | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Phillip Lester |
| Correspondent | Phillip Lester TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2012-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54806017511765 | K122249 | 000 |
| 54806017508192 | K122249 | 000 |
| 54806017508178 | K122249 | 000 |
| 34806017509720 | K122249 | 000 |
| 34806017509713 | K122249 | 000 |
| 34806017509706 | K122249 | 000 |
| 54806017509694 | K122249 | 000 |
| 34806017509263 | K122249 | 000 |
| 54806017509250 | K122249 | 000 |
| 54806017508208 | K122249 | 000 |
| 54806017508222 | K122249 | 000 |
| 54806017508512 | K122249 | 000 |
| 54806017508444 | K122249 | 000 |
| 54806017508437 | K122249 | 000 |
| 54806017508420 | K122249 | 000 |
| 54806017508413 | K122249 | 000 |
| 54806017508253 | K122249 | 000 |
| 54806017508246 | K122249 | 000 |
| 54806017508239 | K122249 | 000 |
| 54806017509236 | K122249 | 000 |