510(k) K173545
K173545 is an FDA 510(k) premarket notification submitted by Temed for the device "TEMED Gas Diffuser". The FDA issued a decision of Substantially Equivalent on Feb 14, 2018. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 14, 2018
- Date Received
- Nov 16, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type
- 510(k)