K964387 is an FDA 510(k) clearance for the POINT OF USE II SHARPS-A-GATOR. This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).
Submitted by Graphic Controls Corp. (Chatsworth, US). The FDA issued a Cleared decision on March 27, 1997, 143 days after receiving the submission on November 4, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K964387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1996 |
| Decision Date | March 27, 1997 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MMK — Container, Sharps |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |