The following data is part of a premarket notification filed by Cd Medical, Inc. with the FDA for Wurtz Choley Clip (tm).
Device ID | K901520 |
510k Number | K901520 |
Device Name: | WURTZ CHOLEY CLIP (TM) |
Classification | Catheter, Cholangiography |
Applicant | CD MEDICAL, INC. 1709 QUEENSBURY CIRCLE Hoffman Estates, IL 60195 |
Contact | Patricia K O'gorman |
Correspondent | Patricia K O'gorman CD MEDICAL, INC. 1709 QUEENSBURY CIRCLE Hoffman Estates, IL 60195 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-02 |
Decision Date | 1990-06-26 |