The following data is part of a premarket notification filed by Master & Frank Ent. Co., Ltd. with the FDA for Master & Frank Surgical Gowns (sterile).
| Device ID | K012186 |
| 510k Number | K012186 |
| Device Name: | MASTER & FRANK SURGICAL GOWNS (STERILE) |
| Classification | Gown, Surgical |
| Applicant | MASTER & FRANK ENT. CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich MASTER & FRANK ENT. CO., LTD. 3892 SOUTH AMERICA WEST TRAIL Flagstaff, AZ 86001 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-12 |
| Decision Date | 2001-12-07 |
| Summary: | summary |