The following data is part of a premarket notification filed by Bam Corporation Limited with the FDA for Safecare Open Back Protective Gowns And Valuecare Open Back Protective Gowns.
| Device ID | K160337 |
| 510k Number | K160337 |
| Device Name: | Safecare Open Back Protective Gowns And ValueCare Open Back Protective Gowns |
| Classification | Gown, Isolation, Surgical |
| Applicant | BAM CORPORATION LIMITED NO. 138 SHATIN RURAL COMMITTEE ROAD, SHATIN, N.T. UNIT 1706, TOWER 2, GRAND CENTRAL PLAZA Hong Kong, CN |
| Contact | Mary Mejaes |
| Correspondent | Mary Mejaes BAM CORPORATION LIMITED NO. 138 SHATIN RURAL COMMITTEE ROAD, SHATIN, N.T. UNIT 1706, TOWER 2, GRAND CENTRAL PLAZA Hong Kong, CN |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2017-07-07 |
| Summary: | summary |