510(k) K770724
K770724 is an FDA 510(k) premarket notification submitted by Chattanooga Pharmacal Co. for the device "TRACTION DEVICES, INTERMITTENT, TX". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code IRS (Head Halter, Traction), a Class I device regulated under 21 CFR 890.5925. Chattanooga Pharmacal Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1977
- Date Received
- April 19, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Head Halter, Traction
- Device Class
- Class I
- Regulation Number
- 890.5925
- Review Panel
- PM
- Submission Type