510(k) K821591
K821591 is an FDA 510(k) premarket notification submitted by Getinge International, Inc. for the device "STEAM STERILIZATION EQUIPMENT". The FDA issued a decision of Substantially Equivalent on June 22, 1982. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Getinge International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1982
- Date Received
- June 1, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type