510(k) K761313
K761313 is an FDA 510(k) premarket notification submitted by Hosmer Dorrance Corp. for the device "4-BAR KNEE-SHIN SET-UP". The FDA issued a decision of Substantially Equivalent on January 10, 1977. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Hosmer Dorrance Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1977
- Date Received
- December 13, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Non-Measuring
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type