The following data is part of a premarket notification filed by Penox Technologies, Inc. with the FDA for T-handle Adapter, U-handle & L Handler Adapter.
| Device ID | K851215 |
| 510k Number | K851215 |
| Device Name: | T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER |
| Classification | Yoke Assembly, Medical Gas |
| Applicant | PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston, PA 18640 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston, PA 18640 |
| Product Code | CAM |
| CFR Regulation Number | 868.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-06-18 |