The following data is part of a premarket notification filed by Griffith-lucas Llc with the FDA for Surgical Drape.
| Device ID | K140195 |
| 510k Number | K140195 |
| Device Name: | SURGICAL DRAPE |
| Classification | Drape, Surgical |
| Applicant | GRIFFITH-LUCAS LLC 7TH FLOOR, JINGUI BUSINESS BUILDING NO.982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu GRIFFITH-LUCAS LLC 7TH FLOOR, JINGUI BUSINESS BUILDING NO.982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-09-10 |
| Summary: | summary |