The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Sterigage Eo Ethyl. Oxide Steril. Indic..
| Device ID | K802634 |
| 510k Number | K802634 |
| Device Name: | STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ORGANON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-22 |
| Decision Date | 1980-12-11 |