510(k) K844411
K844411 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "SCRUB MATE DRY STERILE SCRUB BRUSH". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. American Sterilizer Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1984
- Date Received
- November 14, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Scrub, Operating-Room
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type