510(k) K792629
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1980
- Date Received
- December 19, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Binder, Elastic
- Device Class
- Class I
- Regulation Number
- 880.5160
- Review Panel
- HO
- Submission Type