510(k) K964256

CYGNUS INSTRUMENT PROTECTORS by Madison Polymeric Engineering — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
October 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type