The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Sullivan Variable Stiffness Cable.
Device ID | K901610 |
510k Number | K901610 |
Device Name: | SULLIVAN VARIABLE STIFFNESS CABLE |
Classification | Colonoscope And Accessories, Flexible/rigid |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Contact | F Marshall |
Correspondent | F Marshall WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Product Code | FDF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-06 |
Decision Date | 1990-06-29 |