The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Barrier Surgical Drapes.
| Device ID | K051625 |
| 510k Number | K051625 |
| Device Name: | BARRIER SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | MOLNLYCKE HEALTH CARE, INC. 826 NEWTOWN-YARDLEY RD. Newtown, PA 18940 |
| Contact | John Clay |
| Correspondent | John Clay MOLNLYCKE HEALTH CARE, INC. 826 NEWTOWN-YARDLEY RD. Newtown, PA 18940 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-07-14 |
| Summary: | summary |