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 |