The following data is part of a premarket notification filed by Med Textile, Llc with the FDA for Bp Cuff Barrier 1081789, Bp Cuff Barrier, Plastic Coated 1030193.
| Device ID | K032568 |
| 510k Number | K032568 |
| Device Name: | BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 |
| Classification | Blood Pressure Cuff |
| Applicant | MED TEXTILE, LLC 14300 WOOD DUCK LANE Colonial Heights, VA 23834 |
| Contact | Brittney Gill |
| Correspondent | Brittney Gill MED TEXTILE, LLC 14300 WOOD DUCK LANE Colonial Heights, VA 23834 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-20 |
| Decision Date | 2004-04-29 |