510(k) K821801
K821801 is an FDA 510(k) premarket notification submitted by Bel-Med, Inc. for the device "NORSEN DEBRIDER". The FDA issued a decision of Substantially Equivalent on July 28, 1982. The device falls under product code GED (Brush, Dermabrasion, Manual), a Class I device regulated under 21 CFR 878.4800. Bel-Med, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1982
- Date Received
- June 15, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Dermabrasion, Manual
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type