The following data is part of a premarket notification filed by Kofu Factory Of Terumo Corp. with the FDA for Terumo Micro Tapered Pen Needle.
| Device ID | K052561 |
| 510k Number | K052561 |
| Device Name: | TERUMO MICRO TAPERED PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | KOFU FACTORY OF TERUMO CORP. 1727-1 TSUIJIARAI, SHOWA-CHO Nakakoma-gun, Yamanashi, JP 409-3853 |
| Contact | Barbara Smith |
| Correspondent | Barbara Smith KOFU FACTORY OF TERUMO CORP. 1727-1 TSUIJIARAI, SHOWA-CHO Nakakoma-gun, Yamanashi, JP 409-3853 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2005-11-23 |
| Summary: | summary |