FDA 510(k) Application Details - K022054

Device Classification Name Tonometer, Manual

  More FDA Info for this Device
510(K) Number K022054
Device Name Tonometer, Manual
Applicant C.S.O. S.R.L.
197 BELVOIR RD.
WILLIAMSVILLE, NY 14221 US
Other 510(k) Applications for this Company
Contact R. BRENT MINER
Other 510(k) Applications for this Contact
Regulation Number 886.1930

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

  More FDA Info for this Product Code
Date Received 06/24/2002
Decision Date 08/06/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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