510(k) K811176
K811176 is an FDA 510(k) premarket notification submitted by The Tiggs Co. for the device "TIGGES SPINAL". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code IPW (Orthosis, Sacroiliac, Soft), a Class I device regulated under 21 CFR 890.3490.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1981
- Date Received
- April 28, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Sacroiliac, Soft
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type