The following data is part of a premarket notification filed by Bam Corp., Ltd. with the FDA for Bam Standard Surgical Gown, Bam Reinforced Surgical Gown, Bam Ultra Reinforced Surgical Gown.
| Device ID | K093835 |
| 510k Number | K093835 |
| Device Name: | BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | BAM CORP., LTD. UNIT 1706, TOWER 2, GRAND CNTL PLAZA, NO.138 SHATIN RURAL Committee Rd.,shatin, N.t., HK |
| Contact | Mary Mejaes |
| Correspondent | Mary Mejaes BAM CORP., LTD. UNIT 1706, TOWER 2, GRAND CNTL PLAZA, NO.138 SHATIN RURAL Committee Rd.,shatin, N.t., HK |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-15 |
| Decision Date | 2011-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08683105129450 | K093835 | 000 |
| 08683105129320 | K093835 | 000 |
| 08683105129337 | K093835 | 000 |
| 08683105129344 | K093835 | 000 |
| 08683105129351 | K093835 | 000 |
| 08683105129412 | K093835 | 000 |
| 08683105129429 | K093835 | 000 |
| 08683105129436 | K093835 | 000 |
| 08683105129443 | K093835 | 000 |
| 08683105129313 | K093835 | 000 |