510(k) K903544
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