The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Safeguard 24 Cm Pressure Assisted Dressing.
| Device ID | K062569 |
| 510k Number | K062569 |
| Device Name: | SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING |
| Classification | Clamp, Vascular |
| Applicant | DATASCOPE CORP. 1300 MACARTHUR BLVD Mahwah, NJ 07430 |
| Contact | Susan Mandy |
| Correspondent | Susan Mandy DATASCOPE CORP. 1300 MACARTHUR BLVD Mahwah, NJ 07430 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2007-02-14 |
| Summary: | summary |