510(k) K811688

TUNGSTEN SYRINGE SHIELD by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code IWR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Syringe, Lead
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type