510(k) K921613
K921613 is an FDA 510(k) premarket notification submitted by Dept. of the Army for the device "STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510". The FDA issued a decision of Substantially Equivalent on January 29, 1993. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Dept. of the Army has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1993
- Date Received
- April 6, 1992
- 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