510(k) K941991

IN-ROOM AND SHARPSTAR by Sage Products, Inc. — Product Code MMK

K941991 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "IN-ROOM AND SHARPSTAR". The FDA issued a decision of Substantially Equivalent on August 29, 1994. 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
August 29, 1994
Date Received
April 25, 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