510(k) K844654

SHARP COLLECTION SYSTEM-SHARP-A-GATOR by Devon Industries, Inc. — Product Code MMK

K844654 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "SHARP COLLECTION SYSTEM-SHARP-A-GATOR". The FDA issued a decision of Substantially Equivalent on December 12, 1984. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1984
Date Received
November 29, 1984
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