The following data is part of a premarket notification filed by Langford Ic Systems, Inc. with the FDA for Manzi Mach 1 Instrument Cleaner-processor System, Manzi Detergent Md10, Manzi Sterilant Ms10, Manzi Chemical Indicator.
| Device ID | K060458 |
| 510k Number | K060458 |
| Device Name: | MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | LANGFORD IC SYSTEMS, INC. 141 WASHINGTON STREET East Walpole, MA 02032 |
| Contact | Jimmie T Johnston |
| Correspondent | Jimmie T Johnston LANGFORD IC SYSTEMS, INC. 141 WASHINGTON STREET East Walpole, MA 02032 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-22 |
| Decision Date | 2006-10-12 |
| Summary: | summary |