510(k) K001236
K001236 is an FDA 510(k) premarket notification submitted by R-Med, Inc. for the device "RIZA BAND STRETCHER (RBS)-60000". The FDA issued a decision of Substantially Equivalent on July 17, 2000. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. R-Med, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2000
- Date Received
- April 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Hemorrhoidal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type