The following data is part of a premarket notification filed by Far East Science & Technology Development Co., Ltd with the FDA for Far-east Shoe Covers.
| Device ID | K971191 |
| 510k Number | K971191 |
| Device Name: | FAR-EAST SHOE COVERS |
| Classification | Cover, Shoe, Operating-room |
| 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 | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-07-10 |