The following data is part of a premarket notification filed by Medical Technologies International, Inc. with the FDA for Family First Aid Kit.
Device ID | K935131 |
510k Number | K935131 |
Device Name: | FAMILY FIRST AID KIT |
Classification | Latex Patient Examination Glove |
Applicant | MEDICAL TECHNOLOGIES INTERNATIONAL, INC. 26424-200TH AVE. S.E. Kent, WA 98042 |
Contact | Craig M Matthews |
Correspondent | Craig M Matthews MEDICAL TECHNOLOGIES INTERNATIONAL, INC. 26424-200TH AVE. S.E. Kent, WA 98042 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-28 |
Decision Date | 1994-03-23 |