The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Nasogastric Tube Attachment Device.
Device ID | K953232 |
510k Number | K953232 |
Device Name: | HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE |
Classification | Tubes, Gastrointestinal (and Accessories) |
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 | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-10 |
Decision Date | 1995-08-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10610075166395 | K953232 | 000 |