FDA 510(k) Application Details - K983756

Device Classification Name Implant, Malar

  More FDA Info for this Device
510(K) Number K983756
Device Name Implant, Malar
Applicant SURGICAL TECHNOLOGY LABORATORIES, INC.
1588 EAST 40TH ST.
CLEVELAND, OH 44103 US
Other 510(k) Applications for this Company
Contact RICHARD T NOCK
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 10/22/1998
Decision Date 11/20/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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