The following data is part of a premarket notification filed by Ashton Medical Products, Inc. with the FDA for Surgical Mask/dental Mask.
| Device ID | K895077 |
| 510k Number | K895077 |
| Device Name: | SURGICAL MASK/DENTAL MASK |
| Classification | Mask, Surgical |
| Applicant | ASHTON MEDICAL PRODUCTS, INC. 11651 MONARCH ST. Garden Grove, CA 92641 |
| Contact | James Lenick |
| Correspondent | James Lenick ASHTON MEDICAL PRODUCTS, INC. 11651 MONARCH ST. Garden Grove, CA 92641 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1989-11-03 |