510(k) K830842
K830842 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "OB HELP ARM". The FDA issued a decision of Substantially Equivalent on Apr 5, 1983. The device falls under product code ILE (Sling, Arm, Overhead Supported), a Class I device regulated under 21 CFR 890.3475. Lic-Orthion has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 5, 1983
- Date Received
- Mar 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sling, Arm, Overhead Supported
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type
- 510(k) Exempt