510(k) K761128
K761128 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "LATERAL TRUNK SUPPORTS". The FDA issued a decision of Substantially Equivalent on December 2, 1976. The device falls under product code IPT (Orthosis, Thoracic), a Class I device regulated under 21 CFR 890.3490. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1976
- Date Received
- November 19, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Thoracic
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type