510(k) K884374
K884374 is an FDA 510(k) premarket notification submitted by Kalajian Ent. for the device "E.T. PUFFER". The FDA issued a decision of Substantially Equivalent on November 23, 1988. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Kalajian Ent. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1988
- Date Received
- October 18, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Airway (Extension)
- Device Class
- Class I
- Regulation Number
- 868.5810
- Review Panel
- AN
- Submission Type