The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Compleat Surgical Mask.
| Device ID | K962654 |
| 510k Number | K962654 |
| Device Name: | COMPLEAT SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | CARL PARKER ASSOCIATES, INC. 275 OSER AVE. Hauppauge, NY 11788 |
| Contact | Andrew Parker |
| Correspondent | Andrew Parker CARL PARKER ASSOCIATES, INC. 275 OSER AVE. Hauppauge, NY 11788 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1997-01-27 |
| Summary: | summary |