The following data is part of a premarket notification filed by Carl Parker Associates, Inc. with the FDA for Dental Face Masks, Polyester.
| Device ID | K871558 |
| 510k Number | K871558 |
| Device Name: | DENTAL FACE MASKS, POLYESTER |
| Classification | Mask, Surgical |
| Applicant | CARL PARKER ASSOCIATES, INC. 175M COMMERCE DR. P.O. BOX 12084 Hauppauge, NY 11788 |
| Contact | Carl Parker |
| Correspondent | Carl Parker CARL PARKER ASSOCIATES, INC. 175M COMMERCE DR. P.O. BOX 12084 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 | 1987-04-22 |
| Decision Date | 1987-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843471147716 | K871558 | 000 |
| 20843471137592 | K871558 | 000 |