510(k) K941499
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- July 20, 1994
- Date Received
- March 29, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tape And Bandage, Adhesive
- Device Class
- Class I
- Regulation Number
- 880.5240
- Review Panel
- SU
- Submission Type