The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Pediatric Sucker.
| Device ID | K820638 |
| 510k Number | K820638 |
| Device Name: | PEDIATRIC SUCKER |
| Classification | Instrument, Surgical, Disposable |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-04-09 |