The following data is part of a premarket notification filed by Ulti Med, Inc. with the FDA for Ulti Guard Home Insulin Syringe Container.
Device ID | K021983 |
510k Number | K021983 |
Device Name: | ULTI GUARD HOME INSULIN SYRINGE CONTAINER |
Classification | Container, Sharps |
Applicant | ULTI MED, INC. 287 EAST SIXTH ST. St. Paul, MN 55101 |
Contact | Charles W Erickson |
Correspondent | Charles W Erickson ULTI MED, INC. 287 EAST SIXTH ST. St. Paul, MN 55101 |
Product Code | MMK |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-18 |
Decision Date | 2002-09-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20357515093558 | K021983 | 000 |
20357515093350 | K021983 | 000 |
20357515094593 | K021983 | 000 |
20357515094395 | K021983 | 000 |
20357515094197 | K021983 | 000 |