510(k) K864108
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1986
- Date Received
- October 21, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cushion, Flotation
- Device Class
- Class I
- Regulation Number
- 890.3175
- Review Panel
- PM
- Submission Type