The following data is part of a premarket notification filed by Medical Concepts Development, Inc. with the FDA for Surgical Packs, Kits And Trays.
Device ID | K861530 |
510k Number | K861530 |
Device Name: | SURGICAL PACKS, KITS AND TRAYS |
Classification | Tray, Surgical, Instrument |
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 | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-24 |
Decision Date | 1986-05-30 |