The following data is part of a premarket notification filed by Biomedical Waste Systems, Inc. with the FDA for Big Phil.
| Device ID | K946027 |
| 510k Number | K946027 |
| Device Name: | BIG PHIL |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BIOMEDICAL WASTE SYSTEMS, INC. 200 HIGH ST. Boston, MA 02110 |
| Contact | Michael H King |
| Correspondent | Michael H King BIOMEDICAL WASTE SYSTEMS, INC. 200 HIGH ST. Boston, MA 02110 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-09 |
| Decision Date | 1995-01-26 |