FDA 510(k) Application Details - K952545

Device Classification Name Chamber, Hyperbaric

  More FDA Info for this Device
510(K) Number K952545
Device Name Chamber, Hyperbaric
Applicant WRIGHT INDUSTRIES
13760 SOUTH GRAMERCY PLACE
GARDENA, CA 90249 US
Other 510(k) Applications for this Company
Contact CHARLES WRIGHT
Other 510(k) Applications for this Contact
Regulation Number 868.5470

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

  More FDA Info for this Product Code
Date Received 06/02/1995
Decision Date 05/28/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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