510(k) K903544

CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS by J.J. Skinner, Inc. — Product Code LRP

K903544 is an FDA 510(k) premarket notification submitted by J.J. Skinner, Inc. for the device "CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS". The FDA issued a decision of Substantially Equivalent (with conditions) on August 31, 1990. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. J.J. Skinner, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
August 31, 1990
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type