510(k) K896511

DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL by E.I. Dupont DE Nemours & Co., Inc. — Product Code KPY

K896511 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
November 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type