The following data is part of a premarket notification filed by Medegen Medical Manufacturing Services with the FDA for Tru-swab Stocock.
| Device ID | K052330 |
| 510k Number | K052330 |
| Device Name: | TRU-SWAB STOCOCK |
| Classification | Stopcock, I.v. Set |
| Applicant | MEDEGEN MEDICAL MANUFACTURING SERVICES 930 WANAMAKER AVE. Ontario, CA 91761 |
| Contact | Tim Truitt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-09-09 |