The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Solopicc 24 (60cm) 20ga Catheter.
| Device ID | K954428 |
| 510k Number | K954428 |
| Device Name: | SOLOPICC 24 (60CM) 20GA CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 1840 INDUSTRIAL DR., SUITE 200 Libertyville, IL 60048 |
| Contact | Ronald Haselhorst |
| Correspondent | Ronald Haselhorst DOUGLAS MEDICAL PRODUCTS CORP. 1840 INDUSTRIAL DR., SUITE 200 Libertyville, IL 60048 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-22 |
| Decision Date | 1996-03-28 |
| Summary: | summary |