The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Defend Fluid Resistant Pleated Mask.
| Device ID | K971130 |
| 510k Number | K971130 |
| Device Name: | DEFEND FLUID RESISTANT PLEATED MASK |
| Classification | Mask, Surgical |
| Applicant | CARL PARKER ASSOCIATES, INC. 8309 BRYANT DR. Bethesda, MD 20817 |
| Contact | Neal Dunning |
| Correspondent | Neal Dunning CARL PARKER ASSOCIATES, INC. 8309 BRYANT DR. Bethesda, MD 20817 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-27 |
| Decision Date | 1997-06-27 |
| Summary: | summary |