510(k) K781447
K781447 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "THREADED ROD CLAMP". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1978
- Date Received
- August 23, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type