The following data is part of a premarket notification filed by American Mcgaw with the FDA for Ethylene Oxide Steriliz. Parametric Rel..
| Device ID | K822240 |
| 510k Number | K822240 |
| Device Name: | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. |
| Classification | Assembly, Thigh/knee/shank/ankle/foot, External |
| Applicant | AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
| Contact | Floyd Benjamin |
| Correspondent | Floyd Benjamin AMERICAN MCGAW P.O. BOX 1187 Santa Ana, CA 92711 |
| Product Code | KFX |
| CFR Regulation Number | 890.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-27 |
| Decision Date | 1982-12-30 |