Remunity Pump For Remodulin (treprostinil) Injection
Infusion Pump, Drug Specific, Pharmacy-filled
DEKA Research And Development
The following data is part of a premarket notification filed by Deka Research And Development with the FDA for Remunity Pump For Remodulin (treprostinil) Injection.
Pre-market Notification Details
| Device ID | K202690 |
| 510k Number | K202690 |
| Device Name: | Remunity Pump For Remodulin (treprostinil) Injection |
| Classification | Infusion Pump, Drug Specific, Pharmacy-filled |
| Applicant | DEKA Research And Development 340 Commercial Street Manchester, NH 03101 |
| Contact | Paul Smolenski |
| Correspondent | Paul Smolenski DEKA Research And Development 340 Commercial Street Manchester, NH 03101 |
| Product Code | QJY |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2020-12-30 |
Trademark Results [Remunity Pump For Remodulin (treprostinil) Injection]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION 88345768 not registered Live/Pending |
United Therapeutics Corporation 2019-03-19 |
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