FDA 510(k) Application Details - K954990

Device Classification Name	Dam, Rubber   More FDA Info for this Device
510(K) Number	K954990
Device Name	Dam, Rubber
Applicant	THE HYGENIC CORP. 1245 HOME AVE. AKRON, OH 44310 US Other 510(k) Applications for this Company
Contact	HANK JUSKE Other 510(k) Applications for this Contact
Regulation Number	872.6300   More FDA Info for this Regulation Number
Classification Product Code	EIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/1995
Decision Date	01/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review