510(k) K943658

CHEMOTHERAPY WASTE DISPOSAL CONTAINERS by Sage Products, Inc. — Product Code MMK

K943658 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "CHEMOTHERAPY WASTE DISPOSAL CONTAINERS". The FDA issued a decision of Substantially Equivalent on March 22, 1995. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Sage Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1995
Date Received
July 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type