The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Pericardiocentesis Kit.
| Device ID | K802289 |
| 510k Number | K802289 |
| Device Name: | PERICARDIOCENTESIS KIT |
| Classification | Radioimmunoassay, Digoxin (3-h), Bovine Antibody, Charcoal Sep. |
| Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DOR |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-19 |
| Decision Date | 1980-11-26 |