510(k) K770065
K770065 is an FDA 510(k) premarket notification submitted by Richard F. Kronner, M.D. for the device "ADJUSTABLE ARM SUPPORT". The FDA issued a decision of Substantially Equivalent on February 2, 1977. The device falls under product code IOY (Support, Arm), a Class I device regulated under 21 CFR 890.3475. Richard F. Kronner, M.D. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1977
- Date Received
- January 12, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Arm
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type