510(k) K792064
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