The following data is part of a premarket notification filed by Unimax Medical Systems, Inc. with the FDA for Unimax Suction Irrigation Set.
| Device ID | K103509 |
| 510k Number | K103509 |
| Device Name: | UNIMAX SUCTION IRRIGATION SET |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNIMAX MEDICAL SYSTEMS, INC. NO. 45, MINSHEN RD. DANSHUI TOWN Taipei County, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee UNIMAX MEDICAL SYSTEMS, INC. NO. 45, MINSHEN RD. DANSHUI TOWN Taipei County, TW 251 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851695005371 | K103509 | 000 |
| 10851695005088 | K103509 | 000 |