The following data is part of a premarket notification filed by Solopak Laboratories, Inc. with the FDA for Solopak Pharmaceuticals Inc. Sterile Empty Vial.
| Device ID | K950822 |
| 510k Number | K950822 |
| Device Name: | SOLOPAK PHARMACEUTICALS INC. STERILE EMPTY VIAL |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | SOLOPAK LABORATORIES, INC. 1845 TONNE RD. Elk Grove Village, IL 60007 |
| Contact | Ron Haselhorst |
| Correspondent | Ron Haselhorst SOLOPAK LABORATORIES, INC. 1845 TONNE RD. Elk Grove Village, IL 60007 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-22 |
| Decision Date | 1995-03-22 |