The following data is part of a premarket notification filed by Bam Corp., Ltd. with the FDA for Surgical Face Masks Plus Anti-fog Shield.
| Device ID | K933748 |
| 510k Number | K933748 |
| Device Name: | SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD |
| Classification | Mask, Surgical |
| Applicant | BAM CORP., LTD. WALLPARK COMMERCIAL BLDG. RM. 1604-05, 10-12 CHATHAM CT. Kowloon, HK |
| Contact | Mary Mejaes |
| Correspondent | Mary Mejaes BAM CORP., LTD. WALLPARK COMMERCIAL BLDG. RM. 1604-05, 10-12 CHATHAM CT. Kowloon, HK |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-29 |
| Decision Date | 1994-06-17 |