The following data is part of a premarket notification filed by Molnlycke Health Care with the FDA for Barrier Surgical Gowns.
| Device ID | K050786 |
| 510k Number | K050786 |
| Device Name: | BARRIER SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | MOLNLYCKE HEALTH CARE 826 NEWTON YARDLEY RD. Newton, PA 18940 |
| Contact | John Clay |
| Correspondent | John Clay MOLNLYCKE HEALTH CARE 826 NEWTON YARDLEY RD. Newton, PA 18940 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-28 |
| Decision Date | 2005-05-09 |
| Summary: | summary |