510(k) K802271

THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC by The Anspach Effort, Inc. — Product Code BWN

K802271 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
September 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type