FDA 510(k) Application Details - K990671

Device Classification Name Sponge, Ophthalmic

  More FDA Info for this Device
510(K) Number K990671
Device Name Sponge, Ophthalmic
Applicant HURRICANE MEDICAL
2331K 63RD AVE. EAST
BRADENTON, FL 34203 US
Other 510(k) Applications for this Company
Contact DAVID A CLAPP
Other 510(k) Applications for this Contact
Regulation Number 886.4790

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

  More FDA Info for this Product Code
Date Received 03/02/1999
Decision Date 05/10/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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