510(k) K952784

OXBORO-MEDICAL CAUTERY TIP CLEANER by Oxboro Medical Intl., Inc. — Product Code HQP

K952784 is an FDA 510(k) premarket notification submitted by Oxboro Medical Intl., Inc. for the device "OXBORO-MEDICAL CAUTERY TIP CLEANER". The FDA issued a decision of Substantially Equivalent on July 13, 1995. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Oxboro Medical Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1995
Date Received
June 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Battery-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type