510(k) K060458
K060458 is an FDA 510(k) premarket notification submitted by Langford IC Systems, Inc. for the device "MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on October 12, 2006. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Langford IC Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2006
- Date Received
- February 22, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Cleaning, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- HO
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).