510(k) K791248
K791248 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "SECUTE ELBOW BAND". The FDA issued a decision of Substantially Equivalent on Jul 24, 1979. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 1979
- Date Received
- Jul 6, 1979
- 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
- 510(k) Exempt