510(k) K001236

RIZA BAND STRETCHER (RBS)-60000 by R-Med, Inc. — Product Code FHN

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