The following data is part of a premarket notification filed by H & W Technology, Llc with the FDA for H & W Hospital Ethylene Oxide Sterilizer Control System.
| Device ID | K014013 |
| 510k Number | K014013 |
| Device Name: | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM |
| Classification | Sterilizer, Ethylene-oxide Gas |
| Applicant | H & W TECHNOLOGY, LLC P.O. BOX 20281 Rochester, NY 14602 -0281 |
| Contact | Charles O Hancock |
| Correspondent | Charles O Hancock H & W TECHNOLOGY, LLC P.O. BOX 20281 Rochester, NY 14602 -0281 |
| Product Code | FLF |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-05 |
| Decision Date | 2003-06-25 |
| Summary: | summary |