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 |