510(k) K830266
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1983
- Date Received
- January 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauze/Sponge, Internal
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type