The following data is part of a premarket notification filed by Far East Science & Technology Development Co., Ltd with the FDA for Far-east Bouffant Caps.
| Device ID | K970988 |
| 510k Number | K970988 |
| Device Name: | FAR-EAST BOUFFANT CAPS |
| Classification | Accessory, Surgical Apparel |
| Applicant | FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD 196 LUOYU ROAD Wuhan, CN 430079 P.r |
| Contact | Ping Jiang |
| Correspondent | Ping Jiang FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD 196 LUOYU ROAD Wuhan, CN 430079 P.r |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-18 |
| Decision Date | 1997-07-10 |