FDA 510(k) Application Details - K011979

Device Classification Name	More FDA Info for this Device
510(K) Number	K011979
Device Name	ALLERSHARP ALLERGY SKIN TESTER
Applicant	HMB MEDICAL CONCEPTS, LTD. 1695 RIDGE HAVEN RUN ALPHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	GAVIN MCLACHLAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2001
Decision Date	09/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review