510(k) K955084

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

K955084 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ASPACH 65,000 (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on January 17, 1996. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.