510(k) K870780

ACROMED WALLIE-HEINIG OSTEOTOMES by Buckman Co., Inc. — Product Code HWM

K870780 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED WALLIE-HEINIG OSTEOTOMES". The FDA issued a decision of Substantially Equivalent on March 9, 1987. The device falls under product code HWM (Osteotome), a Class I device regulated under 21 CFR 878.4800. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osteotome
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type