The following data is part of a premarket notification filed by Plastmed, Ltd. with the FDA for Equashield System.
Device ID | K083152 |
510k Number | K083152 |
Device Name: | EQUASHIELD SYSTEM |
Classification | Set, I.v. Fluid Transfer |
Applicant | PLASTMED, LTD. BUILDING 7 P.O.B. 26 Tefen Industrial Park, IL 24959 |
Contact | Elissa Burg |
Correspondent | Elissa Burg PLASTMED, LTD. BUILDING 7 P.O.B. 26 Tefen Industrial Park, IL 24959 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-24 |
Decision Date | 2009-02-02 |
Summary: | summary |