FDA 510(k) Application Details - K823693

Device Classification Name Needle, Hypodermic, Single Lumen

  More FDA Info for this Device
510(K) Number K823693
Device Name Needle, Hypodermic, Single Lumen
Applicant OCEAN MEDICAL PRODUCTS, LTD.

, US
Other 510(k) Applications for this Company
Regulation Number 880.5570

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

  More FDA Info for this Product Code
Date Received 12/08/1982
Decision Date 02/07/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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