The following data is part of a premarket notification filed by Bam Corp., Ltd. with the FDA for Disposable Surgical Mask (modified).
| Device ID | K931580 |
| 510k Number | K931580 |
| Device Name: | DISPOSABLE SURGICAL MASK (MODIFIED) |
| 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 | 1993-03-30 |
| Decision Date | 1994-05-02 |