510(k) K896794

SPECIMEN CONTAINER by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code LIO

K896794 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "SPECIMEN CONTAINER". The FDA issued a decision of Substantially Equivalent on March 1, 1990. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1990
Date Received
December 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type