510(k) K954314
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1995
- Date Received
- September 15, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Surgical Apparel
- Device Class
- Class I
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type