The following data is part of a premarket notification filed by Master & Frank Enterprses Co.ltd. with the FDA for Master & Frank Surgical Drapes (sterile).
| Device ID | K020393 |
| 510k Number | K020393 |
| Device Name: | MASTER & FRANK SURGICAL DRAPES (STERILE) |
| Classification | Drape, Surgical |
| Applicant | MASTER & FRANK ENTERPRSES CO.LTD. 15F-1 NO 57 SEC 2 TUN HWA SOUTH RD Taipei, TW |
| Contact | Frank Wu |
| Correspondent | Frank Wu MASTER & FRANK ENTERPRSES CO.LTD. 15F-1 NO 57 SEC 2 TUN HWA SOUTH RD Taipei, TW |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-06 |
| Decision Date | 2002-05-03 |
| Summary: | summary |