The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Dosimetric Release.
| Device ID | K830546 |
| 510k Number | K830546 |
| Device Name: | DOSIMETRIC RELEASE |
| Classification | Evacuator, Gastro-urology |
| Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQT |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-22 |
| Decision Date | 1983-05-25 |