FDA 510(k) Application Details - K102178

Device Classification Name Syringe, Piston

  More FDA Info for this Device
510(K) Number K102178
Device Name Syringe, Piston
Applicant MHC MEDICAL PRODUCTS
8870 RAVELLO CT
NAPLES, FL 34114 US
Other 510(k) Applications for this Company
Contact DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number 880.5860

  More FDA Info for this Regulation Number
Classification Product Code FMF
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/03/2010
Decision Date 09/02/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact