510(k) K061316
K061316 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE SURGICAL SPONGE SCANNER". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code LWH (Counter, Sponge, Surgical), a Class I device regulated under 21 CFR 880.2740. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2006
- Date Received
- May 11, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Sponge, Surgical
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- SU
- Submission Type