510(k) K780234
K780234 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "TRACTION BELT, PELVIC". The FDA issued a decision of Substantially Equivalent on February 23, 1978. The device falls under product code ILZ (Accessories, Traction), a Class I device regulated under 21 CFR 890.5925. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1978
- Date Received
- February 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Traction
- Device Class
- Class I
- Regulation Number
- 890.5925
- Review Panel
- PM
- Submission Type