The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Suture-safe 40 Adhesive Needle Counter.
| Device ID | K821394 |
| 510k Number | K821394 |
| Device Name: | SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER |
| Classification | Container, Sharps |
| Applicant | KLEEN TEST PRODUCTS 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 | 1982-05-11 |
| Decision Date | 1982-06-03 |