The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Cathy Sterile Disposable I.v. Cannula With Catheter.
| Device ID | K042504 |
| 510k Number | K042504 |
| Device Name: | CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 113 CENTRE WEST COURT Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 113 CENTRE WEST COURT Cary, NC 27513 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-15 |
| Decision Date | 2006-01-19 |