The following data is part of a premarket notification filed by Unimax Medical Systems, Inc. with the FDA for Unimax Trocar System.
| Device ID | K112358 |
| 510k Number | K112358 |
| Device Name: | UNIMAX TROCAR SYSTEM |
| 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 | 2011-08-16 |
| Decision Date | 2011-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24714127864987 | K112358 | 000 |
| 00412786063153 | K112358 | 000 |
| 00412786063160 | K112358 | 000 |
| 00412786063177 | K112358 | 000 |
| 00412786063238 | K112358 | 000 |
| 20412786063232 | K112358 | 000 |
| 20412786063249 | K112358 | 000 |
| 20412786063256 | K112358 | 000 |
| 20412786063331 | K112358 | 000 |
| 24714127862495 | K112358 | 000 |
| 24714127864963 | K112358 | 000 |
| 24714127864970 | K112358 | 000 |
| 00412786063146 | K112358 | 000 |