510(k) K955084

ASPACH 65,000 (MODIFICATION) by The Anspach Effort, Inc. — Product Code HSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1996
Date Received
October 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type