The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Sure-count Disposable Needle Counter.
| Device ID | K822735 |
| 510k Number | K822735 |
| Device Name: | SURE-COUNT DISPOSABLE NEEDLE COUNTER |
| Classification | Container, Sharps |
| Applicant | GENEVA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-09 |
| Decision Date | 1983-03-09 |