510(k) K964181
K964181 is an FDA 510(k) premarket notification submitted by Surgitrac Corp. for the device "SPONGETRAC". The FDA issued a decision of Substantially Equivalent on February 26, 1997. The device falls under product code MRL (Scale, Sponge, Surgical, Electrically-Powered), a Class I device regulated under 21 CFR 880.2740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1997
- Date Received
- October 18, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scale, Sponge, Surgical, Electrically-Powered
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- HO
- Submission Type