510(k) K090157

ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5. by Wcm Waste & Compliance Management, Inc. — Product Code MMK

K090157 is an FDA 510(k) premarket notification submitted by Wcm Waste & Compliance Management, Inc. for the device "ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.". The FDA issued a decision of Substantially Equivalent on May 4, 2009. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Wcm Waste & Compliance Management, Inc. has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2009
Date Received
Jan 22, 2009
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
510(k)

Source: FDA 510(k) database entry for K090157. Report a data issue: hello@regdatalab.com.