The following data is part of a premarket notification filed by Medicinelodge, Inc. with the FDA for Zipknot, Model 1017-3000.
Device ID | K072525 |
510k Number | K072525 |
Device Name: | ZIPKNOT, MODEL 1017-3000 |
Classification | Clip, Implantable |
Applicant | MEDICINELODGE, INC. 180 SOUTH 600 WEST Logan, UT 84321 |
Contact | Mary Sinnott |
Correspondent | Mary Sinnott MEDICINELODGE, INC. 180 SOUTH 600 WEST Logan, UT 84321 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-07 |
Decision Date | 2007-10-05 |