The following data is part of a premarket notification filed by Molnlycke Health Care, Inc. with the FDA for Klinidrape Surgical Gowns, Non-reinforced, Basic Protections And Standard Protection.
| Device ID | K000901 |
| 510k Number | K000901 |
| Device Name: | KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION |
| Classification | Gown, Surgical |
| Applicant | MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Contact | Miguel A Negron |
| Correspondent | Miguel A Negron MOLNLYCKE HEALTH CARE, INC. 500 BALDWIN TOWER Eddystone, PA 19022 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-21 |
| Decision Date | 2000-07-05 |