510(k) K811343
K811343 is an FDA 510(k) premarket notification submitted by Deseret Medical, Inc. for the device "HUMERAL FRACTURE CAST BRACE". The FDA issued a decision of Substantially Equivalent on May 28, 1981. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Deseret Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1981
- Date Received
- May 12, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Limb Brace
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type