The following data is part of a premarket notification filed by Solopak Medical Products, Inc. with the FDA for Maxcess Needle Free Connector (8200).
| Device ID | K960661 |
| 510k Number | K960661 |
| Device Name: | MAXCESS NEEDLE FREE CONNECTOR (8200) |
| Classification | Set, Administration, Intravascular |
| Applicant | SOLOPAK MEDICAL PRODUCTS, INC. 1840 INDUSTRIAL DR. SUITE 100 Libertyville, IL 60048 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst SOLOPAK MEDICAL PRODUCTS, INC. 1840 INDUSTRIAL DR. SUITE 100 Libertyville, IL 60048 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-16 |
| Decision Date | 1996-03-21 |
| Summary: | summary |