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 |