510(k) K862160

CAMINO HAND DRILL - MODEL 030 by Camino Laboratories, Inc. — Product Code HBG

K862160 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "CAMINO HAND DRILL - MODEL 030". The FDA issued a decision of Substantially Equivalent on July 18, 1986. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1986
Date Received
June 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type