510(k) K942664

KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM by The Kendal Co. — Product Code JOW

K942664 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 1995. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1995
Date Received
June 6, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type