510(k) K921053
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1992
- Date Received
- March 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ent
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type