The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Colon Decompression Set.
| Device ID | K900035 |
| 510k Number | K900035 |
| Device Name: | WILSON-COOK COLON DECOMPRESSION SET |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| 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 | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-03-07 |