510(k) K873191

ACROMED INTERBODY DEPTH GAUGES by Buckman Co., Inc. — Product Code HTJ

K873191 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED INTERBODY DEPTH GAUGES". The FDA issued a decision of Substantially Equivalent on September 9, 1987. The device falls under product code HTJ (Gauge, Depth), a Class I device regulated under 21 CFR 888.4300. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1987
Date Received
August 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Depth
Device Class
Class I
Regulation Number
888.4300
Review Panel
OR
Submission Type