The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Disposable Scalp Vein Infusion Set.
| Device ID | K953252 |
| 510k Number | K953252 |
| Device Name: | DISPOSABLE SCALP VEIN INFUSION SET |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MYCO MEDICAL SUPPLIES, INC. 6640 PORTSMOUTH LN. Raleigh, NC 27615 |
| Contact | Sanjiv Kumar |
| Correspondent | Sanjiv Kumar MYCO MEDICAL SUPPLIES, INC. 6640 PORTSMOUTH LN. Raleigh, NC 27615 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-12 |
| Decision Date | 1996-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479195651 | K953252 | 000 |
| 08903347003265 | K953252 | 000 |
| 08903347003272 | K953252 | 000 |
| 08903347003289 | K953252 | 000 |
| 08903347003302 | K953252 | 000 |
| 08903347034696 | K953252 | 000 |
| 40612479195507 | K953252 | 000 |
| 40612479195538 | K953252 | 000 |
| 40612479195569 | K953252 | 000 |
| 40612479195590 | K953252 | 000 |
| 40612479195620 | K953252 | 000 |
| 08903347003241 | K953252 | 000 |