The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Sterile Field Saline And Heparin Lock Flush Syringes.
| Device ID | K053120 |
| 510k Number | K053120 |
| Device Name: | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | EXCELSIOR MEDICAL CORP. 1923 HECK AVE. Neptune, NJ 07753 |
| Contact | Ruben Martinez |
| Correspondent | Ruben Martinez EXCELSIOR MEDICAL CORP. 1923 HECK AVE. Neptune, NJ 07753 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-07 |
| Decision Date | 2005-12-09 |
| Summary: | summary |