510(k) K780229
K780229 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "ABDOMINAL BELT". The FDA issued a decision of Substantially Equivalent on March 2, 1978. The device falls under product code KTD (Orthosis, Abdominal), a Class I device regulated under 21 CFR 890.3490. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1978
- Date Received
- February 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Abdominal
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type