The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Ear/ulcer Syringe.
| Device ID | K822754 |
| 510k Number | K822754 |
| Device Name: | EAR/ULCER SYRINGE |
| Classification | Syringe, Ent |
| Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KCP |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-08 |
| Decision Date | 1982-10-04 |