510(k) K882617
K882617 is an FDA 510(k) premarket notification submitted by Brevet, Inc. for the device "BREVET CASSETTE STERILIZATION MODULE". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Brevet, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1988
- Date Received
- June 24, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type