Smart Syringe
Injector And Syringe, Angiographic
Osprey Medical, Inc.
The following data is part of a premarket notification filed by Osprey Medical, Inc. with the FDA for Smart Syringe.
Pre-market Notification Details
| Device ID | K171698 |
| 510k Number | K171698 |
| Device Name: | Smart Syringe |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Osprey Medical, Inc. 5600 Rowland Road Suite 250 Minnetonka, MN 55343 |
| Contact | Melanie Hess |
| Correspondent | Melanie Hess Osprey Medical, Inc. 5600 Rowland Road Suite 250 Minnetonka, MN 55343 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-08 |
| Decision Date | 2017-07-07 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815241020522 | K171698 | 000 |
| 00815241020515 | K171698 | 000 |
| 00815241020508 | K171698 | 000 |
| 00815241020492 | K171698 | 000 |
| 00815241020485 | K171698 | 000 |
Trademark Results [Smart Syringe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMART SYRINGE 85008373 not registered Dead/Abandoned |
Sakharam D. Mahurkar 2010-04-07 |
 SMART SYRINGE 78059084 2832991 Live/Registered |
MAHURKAR, SUDHA S. 2001-04-18 |
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