510(k) K802067
K802067 is an FDA 510(k) premarket notification submitted by Porter Instrument Co., Inc. for the device "CLEAN-AIR POLLUTION REDUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Porter Instrument Co., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1980
- Date Received
- August 27, 1980
- Clearance Type
- Traditional
- 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