510(k) K802634
K802634 is an FDA 510(k) premarket notification submitted by Organon, Inc. for the device "STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Organon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1980
- Date Received
- October 22, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type