The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare(tm) Sterile, Pressure Sore Manage Kit.
Device ID | K890107 |
510k Number | K890107 |
Device Name: | GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT |
Classification | Dressing, Wound, Drug |
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 | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-11 |
Decision Date | 1989-10-24 |