510(k) K891983

CAM-WRAP(TM) NEW STERILIZATION PROCEDURE by Medical Dynamics, Inc. — Product Code KCT

K891983 is an FDA 510(k) premarket notification submitted by Medical Dynamics, Inc. for the device "CAM-WRAP(TM) NEW STERILIZATION PROCEDURE". The FDA issued a decision of Substantially Equivalent on April 19, 1989. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Medical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1989
Date Received
March 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type