The following data is part of a premarket notification filed by Medical Concepts Development, Inc. with the FDA for Coloshield Colonoscopy Drape Model E2000.
| Device ID | K020581 |
| 510k Number | K020581 |
| Device Name: | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 |
| Classification | Drape, Surgical |
| Applicant | MEDICAL CONCEPTS DEVELOPMENT, INC. 2500 VENTURA DR. Woodbury, MN 55125 -3927 |
| Contact | Eric Euteneuer |
| Correspondent | Eric Euteneuer MEDICAL CONCEPTS DEVELOPMENT, INC. 2500 VENTURA DR. Woodbury, MN 55125 -3927 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-21 |
| Decision Date | 2002-09-18 |
| Summary: | summary |