510(k) K954940
K954940 is an FDA 510(k) premarket notification submitted by Mdt Biologic Co. for the device "MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE". The FDA issued a decision of Substantially Equivalent on January 17, 1996. The device falls under product code FTA (Light, Surgical, Accessories), a Class II device regulated under 21 CFR 878.4580. Mdt Biologic Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1996
- Date Received
- October 30, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Accessories
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type