FDA 510(k) Application Details - K964181

Device Classification Name Scale, Sponge, Surgical, Electrically-Powered

  More FDA Info for this Device
510(K) Number K964181
Device Name Scale, Sponge, Surgical, Electrically-Powered
Applicant SURGITRAC CORP.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
Other 510(k) Applications for this Company
Contact JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number 880.2740

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

  More FDA Info for this Product Code
Date Received 10/18/1996
Decision Date 02/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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