510(k) K792248
K792248 is an FDA 510(k) premarket notification submitted by Taylor Medical Equipment for the device "TAYLOR TRACTION CORD". The FDA issued a decision of Substantially Equivalent on November 30, 1979. The device falls under product code HST (Apparatus, Traction, Non-Powered), a Class I device regulated under 21 CFR 888.5850. Taylor Medical Equipment has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1979
- Date Received
- November 7, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Traction, Non-Powered
- Device Class
- Class I
- Regulation Number
- 888.5850
- Review Panel
- NE
- Submission Type