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 |