The following data is part of a premarket notification filed by Medegen Medical Manufacturing Services with the FDA for Maxguard Advanced Luer Activated Device With Antimicrobial.
| Device ID | K083765 |
| 510k Number | K083765 |
| Device Name: | MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL |
| Classification | Set, Administration, Intravascular |
| Applicant | MEDEGEN MEDICAL MANUFACTURING SERVICES 930 WANAMAKER AVE. Ontario, CA 91761 |
| Contact | Matthew Fried |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-18 |
| Decision Date | 2008-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403274341 | K083765 | 000 |
| 50885403235823 | K083765 | 000 |
| 50885403235793 | K083765 | 000 |
| 50885403235786 | K083765 | 000 |
| 50885403235779 | K083765 | 000 |
| 50885403235755 | K083765 | 000 |
| 50885403235748 | K083765 | 000 |