510(k) K953068

OXBORO-MEDICAL FOAM INSTRUMENT HOLDER by Oxboro Medical Intl., Inc. — Product Code KCT

K953068 is an FDA 510(k) premarket notification submitted by Oxboro Medical Intl., Inc. for the device "OXBORO-MEDICAL FOAM INSTRUMENT HOLDER". The FDA issued a decision of Substantially Equivalent on January 23, 1996. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Oxboro Medical Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1996
Date Received
June 30, 1995
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