510(k) K150540
K150540 is an FDA 510(k) premarket notification submitted by Summit Medical, Inc. for the device "Instru-Safe Instrument Protection System". The FDA issued a decision of Substantially Equivalent on Jun 22, 2015. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Summit Medical, Inc. has 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2015
- Date Received
- Mar 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type
- 510(k)