The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare Tracheostomy Trays.
Device ID | K950851 |
510k Number | K950851 |
Device Name: | GENT-L-KARE TRACHEOSTOMY TRAYS |
Classification | Tracheostomy And Nasal Suctioning Kit |
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 | LRQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-24 |
Decision Date | 1995-06-21 |