510(k) K992079

KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 by The Kendall Company, L.P. — Product Code JOW

K992079 is an FDA 510(k) premarket notification submitted by The Kendall Company, L.P. for the device "KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325". The FDA issued a decision of Substantially Equivalent on September 29, 1999. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. The Kendall Company, L.P. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1999
Date Received
June 21, 1999
Clearance Type
Special
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