The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Spiro-flex.
| Device ID | K945565 |
| 510k Number | K945565 |
| Device Name: | SPIRO-FLEX |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | INHALATION PLASTICS 3217 N. KILPATRICK AVE. Chicago, IL 60641 |
| Contact | James Lekkas |
| Correspondent | James Lekkas INHALATION PLASTICS 3217 N. KILPATRICK AVE. Chicago, IL 60641 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-16 |
| Decision Date | 1995-01-13 |