The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Coverd Gianturco-rosch Esophageal Z-stent.
Device ID | K945201 |
510k Number | K945201 |
Device Name: | COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT |
Classification | Prosthesis, Esophageal |
Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Contact | April Lavender |
Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
Product Code | ESW |
CFR Regulation Number | 878.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-25 |
Decision Date | 1995-01-04 |