The following data is part of a premarket notification filed by Pacific Hospital Supply Co., Ltd with the FDA for Max Orient Suction Device For Electrocauterizer.
| Device ID | K111672 |
| 510k Number | K111672 |
| Device Name: | MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PACIFIC HOSPITAL SUPPLY CO., LTD 4F, NO. 160, DAYE RD, BEITOU DIST. Taipei, TW 112 |
| Contact | Irene Lin |
| Correspondent | Tzu- Wei Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-15 |
| Decision Date | 2011-06-29 |