FDA 510(k) Application Details - K981888

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

  More FDA Info for this Device
510(K) Number K981888
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BIO-MEDICAL DEVICES, INC.
1752-A LANGLEY AVE.
IRVINE, CA 92614 US
Other 510(k) Applications for this Company
Contact NICK HERBERT
Other 510(k) Applications for this Contact
Regulation Number 878.4400

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

  More FDA Info for this Product Code
Date Received 05/29/1998
Decision Date 10/15/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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