The following data is part of a premarket notification filed by Epitek, Inc. with the FDA for Anchorage Access Kit.
Device ID | K073507 |
510k Number | K073507 |
Device Name: | ANCHORAGE ACCESS KIT |
Classification | Endoscope Channel Accessory |
Applicant | EPITEK, INC. 4801 W. 81ST STREET SUITE 105 Bloomington, MN 55437 |
Contact | Werner Hampl |
Correspondent | Werner Hampl EPITEK, INC. 4801 W. 81ST STREET SUITE 105 Bloomington, MN 55437 |
Product Code | ODC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-13 |
Decision Date | 2008-03-05 |
Summary: | summary |