The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Drain Tube Attachment.
Device ID | K862573 |
510k Number | K862573 |
Device Name: | HOLLISTER DRAIN TUBE ATTACHMENT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Jerome A Saxon |
Correspondent | Jerome A Saxon 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 | 1986-07-07 |
Decision Date | 1986-09-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20610075097801 | K862573 | 000 |