510(k) K895084

APERTURE by Custom Medical Products, Ltd. — Product Code IZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
August 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aperture, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type