510(k) K951623
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1995
- Date Received
- April 7, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type