510(k) K090157
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)