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 |