510(k) K792064

DELTA ROLLING SELF-LICKING WALKER by Staricat, Inc. — Product Code ITJ

K792064 is an FDA 510(k) premarket notification submitted by Staricat, Inc. for the device "DELTA ROLLING SELF-LICKING WALKER". The FDA issued a decision of Substantially Equivalent on October 30, 1979. The device falls under product code ITJ (Walker, Mechanical), a Class I device regulated under 21 CFR 890.3825.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1979
Date Received
October 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Walker, Mechanical
Device Class
Class I
Regulation Number
890.3825
Review Panel
PM
Submission Type