The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Point Of Use Ii Sharps-a-gator.
| Device ID | K964387 |
| 510k Number | K964387 |
| Device Name: | POINT OF USE II SHARPS-A-GATOR |
| Classification | Container, Sharps |
| Applicant | GRAPHIC CONTROLS CORP. 9530 DESOTO AVE. Chatsworth, CA 91311 -5084 |
| Contact | George Austria |
| Correspondent | George Austria GRAPHIC CONTROLS CORP. 9530 DESOTO AVE. Chatsworth, CA 91311 -5084 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-03-27 |
| Summary: | summary |