The following data is part of a premarket notification filed by App Pharmaceuticals, Llc with the FDA for Heparin Lock Flush Solution Usp, Models 504401, 504411, 504505, 505701, 504901, 1710.
| Device ID | K092938 |
| 510k Number | K092938 |
| Device Name: | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 |
| Classification | Heparin, Vascular Access Flush |
| Applicant | APP PHARMACEUTICALS, LLC 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward APP PHARMACEUTICALS, LLC 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | NZW |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-09-24 |
| Decision Date | 2010-06-18 |
| Summary: | summary |