510(k) K760869
K760869 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "SPLIT CERVICAL COLLAR/HEAD HALTER". The FDA issued a decision of Substantially Equivalent on November 1, 1976. The device falls under product code HSS (Halter, Head, Traction), a Class I device regulated under 21 CFR 888.5890. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1976
- Date Received
- October 18, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Halter, Head, Traction
- Device Class
- Class I
- Regulation Number
- 888.5890
- Review Panel
- PM
- Submission Type