The following data is part of a premarket notification filed by Unimax Medical Systems, Inc. with the FDA for Unmiax Laparoscopic Instrument.
| Device ID | K103508 |
| 510k Number | K103508 |
| Device Name: | UNMIAX LAPAROSCOPIC INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24714127868466 | K103508 | 000 |
| 10851695005286 | K103508 | 000 |
| 10851695005293 | K103508 | 000 |
| 10851695005835 | K103508 | 000 |
| 10851695005910 | K103508 | 000 |
| 00851695005357 | K103508 | 000 |
| 00851695005425 | K103508 | 000 |
| 00851695005654 | K103508 | 000 |
| 00412786063184 | K103508 | 000 |
| 00412786063320 | K103508 | 000 |
| 20412786063324 | K103508 | 000 |
| 24714127862976 | K103508 | 000 |
| 04714127862989 | K103508 | 000 |
| 24714127862990 | K103508 | 000 |
| 24714127865984 | K103508 | 000 |
| 24714127867124 | K103508 | 000 |
| 10851695005163 | K103508 | 000 |