The following data is part of a premarket notification filed by Langford Ic Systems, Inc. with the FDA for Manzi Cleaner System.
| Device ID | K043314 |
| 510k Number | K043314 |
| Device Name: | MANZI CLEANER SYSTEM |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | LANGFORD IC SYSTEMS, INC. 310 S. WILLIAMS BLVD. SUITE 270 Tucson, AZ 85711 |
| Contact | Terry Langford |
| Correspondent | Terry Langford LANGFORD IC SYSTEMS, INC. 310 S. WILLIAMS BLVD. SUITE 270 Tucson, AZ 85711 |
| Product Code | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-01 |
| Decision Date | 2005-06-20 |
| Summary: | summary |