The following data is part of a premarket notification filed by Life Medical Technologies, Inc. with the FDA for Safesharpe (tm) Disposal System.
| Device ID | K925056 |
| 510k Number | K925056 |
| Device Name: | SAFESHARPE (TM) DISPOSAL SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | LIFE MEDICAL TECHNOLOGIES, INC. 3649 WEST 1987 SOUTH Salt Lake City, UT 84104 |
| Contact | David L Vangeison |
| Correspondent | David L Vangeison LIFE MEDICAL TECHNOLOGIES, INC. 3649 WEST 1987 SOUTH Salt Lake City, UT 84104 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-06 |
| Decision Date | 1995-04-21 |