510(k) K935682

LACERATION TRAY by Cush Medical Products — Product Code FRG

K935682 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "LACERATION TRAY". The FDA issued a decision of Substantially Equivalent on February 10, 1994. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Cush Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
November 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type