510(k) K792318

SKIL-CARE TURN AND HOLD PAD by Skil-Care Corp. — Product Code FMR

K792318 is an FDA 510(k) premarket notification submitted by Skil-Care Corp. for the device "SKIL-CARE TURN AND HOLD PAD". The FDA issued a decision of Substantially Equivalent on December 20, 1979. The device falls under product code FMR (Device, Transfer, Patient, Manual), a Class I device regulated under 21 CFR 880.6785. Skil-Care Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1979
Date Received
November 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Transfer, Patient, Manual
Device Class
Class I
Regulation Number
880.6785
Review Panel
HO
Submission Type