510(k) K132729
K132729 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "ISO-GARD MASK". The FDA issued a decision of Substantially Equivalent on January 9, 2014. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2014
- Date Received
- September 3, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Gas-Scavenging
- Device Class
- Class II
- Regulation Number
- 868.5430
- Review Panel
- AN
- Submission Type