510(k) K920842
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1992
- Date Received
- February 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ent Drug
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type