The following data is part of a premarket notification filed by Medical Concepts Development, Inc. with the FDA for Transparent Adhesive Dressing.
Device ID | K924794 |
510k Number | K924794 |
Device Name: | TRANSPARENT ADHESIVE DRESSING |
Classification | Tape And Bandage, Adhesive |
Applicant | MEDICAL CONCEPTS DEVELOPMENT, INC. 2500 VENTURA DR. Woodbury, MN 55125 -3927 |
Contact | Leland W Annett |
Correspondent | Leland W Annett MEDICAL CONCEPTS DEVELOPMENT, INC. 2500 VENTURA DR. Woodbury, MN 55125 -3927 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-23 |
Decision Date | 1993-07-08 |