510(k) K770611
K770611 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "PARALLEL BARS". The FDA issued a decision of Substantially Equivalent on April 8, 1977. The device falls under product code IOE (Bars, Parallel, Exercise), a Class I device regulated under 21 CFR 890.5370. Will Ross Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1977
- Date Received
- March 31, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bars, Parallel, Exercise
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type