The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Excelsior Disposable Syringe W/normal Saline (.9% Sodium Chloride).
Device ID | K962938 |
510k Number | K962938 |
Device Name: | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | EXCELSIOR MEDICAL CORP. P.O. BOX 299 Long Branch, NJ 07740 -0299 |
Contact | David Lumia |
Correspondent | David Lumia EXCELSIOR MEDICAL CORP. P.O. BOX 299 Long Branch, NJ 07740 -0299 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-29 |
Decision Date | 1996-10-25 |