FDA 510(k) Application Details - K963457

Device Classification Name Restraint, Protective

  More FDA Info for this Device
510(K) Number K963457
Device Name Restraint, Protective
Applicant SKIL-CARE CORP.
167 SAW MILL RIVER RD.
YONKERS, NY 10701 US
Other 510(k) Applications for this Company
Contact ARNOLD SILVERMAN
Other 510(k) Applications for this Contact
Regulation Number 880.6760

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

  More FDA Info for this Product Code
Date Received 09/03/1996
Decision Date 10/09/1996
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