The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare Ster Suct Cath Tray W/14 Fr/ster Water.
Device ID | K893135 |
510k Number | K893135 |
Device Name: | GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER |
Classification | Catheter And Tip, Suction |
Applicant | PREMIUM PLASTICS, INC. GENEVA LABORATORIES, INC. P.O. BOX 140, Elkhorn, WI 53121 |
Contact | Gary L Swanson |
Correspondent | Gary L Swanson PREMIUM PLASTICS, INC. GENEVA LABORATORIES, INC. P.O. BOX 140, Elkhorn, WI 53121 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-25 |
Decision Date | 1989-06-22 |