510(k) K961227

JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY by J.J. Skinner, Inc. — Product Code FRG

K961227 is an FDA 510(k) premarket notification submitted by J.J. Skinner, Inc. for the device "JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent on June 10, 1996. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. J.J. Skinner, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1996
Date Received
March 28, 1996
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