510(k) K833187

HALL OSTEON by Amsco Co. — Product Code GET

K833187 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "HALL OSTEON". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
September 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type