The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Pulm O2 Suction Catheter Trays.
| Device ID | K953226 |
| 510k Number | K953226 |
| Device Name: | PULM O2 SUCTION CATHETER TRAYS |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | PREMIUM PLASTICS, INC. 465 WEST CERMAK RD. Chicago, IL 60616 |
| Contact | Gary Garbin |
| Correspondent | Gary Garbin PREMIUM PLASTICS, INC. 465 WEST CERMAK RD. Chicago, IL 60616 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-06 |
| Decision Date | 1995-08-08 |