The following data is part of a premarket notification filed by Kalajian Ent. with the FDA for E.t. Puffer.
| Device ID | K884374 |
| 510k Number | K884374 |
| Device Name: | E.T. PUFFER |
| Classification | Connector, Airway (extension) |
| Applicant | KALAJIAN ENT. P.O. BOX 30401 Long Beach, CA 90853 |
| Contact | W Kalayjian |
| Correspondent | W Kalayjian KALAJIAN ENT. P.O. BOX 30401 Long Beach, CA 90853 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-18 |
| Decision Date | 1988-11-23 |