The following data is part of a premarket notification filed by White Knight Healthcare with the FDA for Dualgard Face Shield.
| Device ID | K934969 |
| 510k Number | K934969 |
| Device Name: | DUALGARD FACE SHIELD |
| Classification | Mask, Surgical |
| Applicant | WHITE KNIGHT HEALTHCARE BON AIRE RD. BOX 367 Childersburg, AL 35044 |
| Contact | Frank R Dastoli |
| Correspondent | Frank R Dastoli WHITE KNIGHT HEALTHCARE BON AIRE RD. BOX 367 Childersburg, AL 35044 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-14 |
| Decision Date | 1994-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814707020551 | K934969 | 000 |
| 20814707020377 | K934969 | 000 |
| 20814707020353 | K934969 | 000 |
| 20814707020346 | K934969 | 000 |
| 20814707020308 | K934969 | 000 |
| 20814707020292 | K934969 | 000 |
| 20814707020278 | K934969 | 000 |
| 20814707020247 | K934969 | 000 |
| 20814707020223 | K934969 | 000 |
| 20814707020018 | K934969 | 000 |
| 20814707020001 | K934969 | 000 |
| 20814707020384 | K934969 | 000 |
| 20814707020513 | K934969 | 000 |
| 20814707020544 | K934969 | 000 |
| 20814707022692 | K934969 | 000 |
| 20814707021497 | K934969 | 000 |
| 10814707021254 | K934969 | 000 |
| 20814707021244 | K934969 | 000 |
| 20814707020698 | K934969 | 000 |
| 20814707020681 | K934969 | 000 |
| 20814707020667 | K934969 | 000 |
| 20814707020537 | K934969 | 000 |
| 20814707020520 | K934969 | 000 |
| 80368001105473 | K934969 | 000 |