The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Lung Biopsy Needle.
Device ID | K897050 |
510k Number | K897050 |
Device Name: | WILSON-COOK LUNG BIOPSY NEEDLE |
Classification | Needle, Aspiration And Injection, Disposable |
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 | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-18 |
Decision Date | 1990-04-16 |