The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Horizontal Drain/tube Attachment Device.
Device ID | K922739 |
510k Number | K922739 |
Device Name: | HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE |
Classification | Catheter, Irrigation |
Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Joseph S Tokarz |
Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Product Code | GBX |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-08 |
Decision Date | 1992-08-06 |