510(k) K771109
K771109 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "ORTHOPEDIC SOFT GOODS". The FDA issued a decision of Substantially Equivalent on June 27, 1977. The device falls under product code HSS (Halter, Head, Traction), a Class I device regulated under 21 CFR 888.5890. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1977
- Date Received
- June 20, 1977
- 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