The following data is part of a premarket notification filed by Hexcel Medical with the FDA for Proposed Controls For Dosimetric Release.
| Device ID | K812068 |
| 510k Number | K812068 |
| Device Name: | PROPOSED CONTROLS FOR DOSIMETRIC RELEASE |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | HEXCEL MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-21 |
| Decision Date | 1981-09-08 |