510(k) K892862

FLEX-CUP PERCUSSOR by Life Design Systems, Inc. — Product Code BYI

K892862 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "FLEX-CUP PERCUSSOR". The FDA issued a decision of Substantially Equivalent on May 25, 1989. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1989
Date Received
April 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type