The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Tutodrop 1 And Tutodrop 2.
| Device ID | K982098 |
| 510k Number | K982098 |
| Device Name: | TUTODROP 1 AND TUTODROP 2 |
| Classification | Set, Administration, Intravascular |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 101 ROSE VALLEY WOODS DR. Cary, NC 27513 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1999-03-01 |