The following data is part of a premarket notification filed by Far East Science & Technology Development Co., Ltd with the FDA for Far-east Barrier Gowns.
| Device ID | K971702 |
| 510k Number | K971702 |
| Device Name: | FAR-EAST BARRIER GOWNS |
| Classification | Gown, Isolation, Surgical |
| Applicant | FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD 11250 DALE ST. #59 Garden Grove, CA 92841 |
| Contact | David Song |
| Correspondent | David Song FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD 11250 DALE ST. #59 Garden Grove, CA 92841 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-08 |
| Decision Date | 1997-07-08 |