The following data is part of a premarket notification filed by Solopak Medical Products, Inc. with the FDA for Maxcess Needlefree - Y- Site (100713).
| Device ID | K970800 |
| 510k Number | K970800 |
| Device Name: | MAXCESS NEEDLEFREE - Y- SITE (100713) |
| Classification | Set, Administration, Intravascular |
| Applicant | SOLOPAK MEDICAL PRODUCTS, INC. 1845 TONNE RD. Elk Grove Village, IL 60007 -5125 |
| Contact | Elizabeth Loya |
| Correspondent | Elizabeth Loya SOLOPAK MEDICAL PRODUCTS, INC. 1845 TONNE RD. Elk Grove Village, IL 60007 -5125 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-04-02 |
| Summary: | summary |