The following data is part of a premarket notification filed by Biomedical Waste Systems, Inc. with the FDA for Sharps Away.
Device ID | K943765 |
510k Number | K943765 |
Device Name: | SHARPS AWAY |
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 | 1994-08-02 |
Decision Date | 1995-07-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B4501380Y0 | K943765 | 000 |
B4501380V0 | K943765 | 000 |
B4501330V0 | K943765 | 000 |
B4501330H0 | K943765 | 000 |
B4501320V0 | K943765 | 000 |
B4501320H0 | K943765 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SHARPS AWAY 78211842 not registered Dead/Abandoned |
United Sterilization of America, Inc. 2003-02-06 |
SHARPS AWAY 73537409 1373006 Dead/Cancelled |
MEDICAL DISPOSAL SYSTEMS 1985-05-13 |