510(k) K892697

E653 OBLONG ABDUCTION BLOCK by Rifton Equipment For the Handicapped — Product Code INW

K892697 is an FDA 510(k) premarket notification submitted by Rifton Equipment For the Handicapped for the device "E653 OBLONG ABDUCTION BLOCK". The FDA issued a decision of Substantially Equivalent on May 9, 1989. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. Rifton Equipment For the Handicapped has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type