The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Teflon Cervical Access Set.
Device ID | K896701 |
510k Number | K896701 |
Device Name: | TEFLON CERVICAL ACCESS SET |
Classification | Dilator, Cervical, Fixed Size |
Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Contact | Michelle Young |
Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
Product Code | HDQ |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-28 |
Decision Date | 1990-09-13 |