The following data is part of a premarket notification filed by Medical Concepts Development, Inc. with the FDA for Acti-gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,d6651, D66xx.
| Device ID | K000442 |
| 510k Number | K000442 |
| Device Name: | ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX |
| Classification | Drape, Surgical |
| Applicant | MEDICAL CONCEPTS DEVELOPMENT, INC. 2500 VENTURA DR. Woodbury, MN 55125 -3927 |
| Contact | David Padget |
| Correspondent | David Padget 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 | 2000-02-10 |
| Decision Date | 2001-04-24 |