The following data is part of a premarket notification filed by Medical Concepts Development, Inc. with the FDA for Disposable Surgical Drapes And Accessories.
Device ID | K861531 |
510k Number | K861531 |
Device Name: | DISPOSABLE SURGICAL DRAPES AND ACCESSORIES |
Classification | Drape, Surgical |
Applicant | MEDICAL CONCEPTS DEVELOPMENT, INC. 330 CHESTER ST. St. Paul, MN 55107 |
Contact | Lee W Annett |
Correspondent | Lee W Annett MEDICAL CONCEPTS DEVELOPMENT, INC. 330 CHESTER ST. St. Paul, MN 55107 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-24 |
Decision Date | 1986-05-23 |