510(k) K935220

CORE PREVENT MATTRESS MODIFICATION by Paladin Medical, Inc. — Product Code FMW

K935220 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "CORE PREVENT MATTRESS MODIFICATION". The FDA issued a decision of Substantially Equivalent on November 29, 1993. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1993
Date Received
October 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type