The following data is part of a premarket notification filed by Unimax Medical Systems, Inc. with the FDA for Unimax Specimen Retrieval System.
| Device ID | K103510 |
| 510k Number | K103510 |
| Device Name: | UNIMAX SPECIMEN RETRIEVAL 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 | 2010-11-29 |
| Decision Date | 2011-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851695005180 | K103510 | 000 |
| 00412786063214 | K103510 | 000 |
| 00412786063207 | K103510 | 000 |
| 00412786063191 | K103510 | 000 |
| 00412786063139 | K103510 | 000 |
| 00412786063122 | K103510 | 000 |
| 00412786063115 | K103510 | 000 |
| 04714127860657 | K103510 | 000 |
| 10851695005798 | K103510 | 000 |
| 10851695005767 | K103510 | 000 |
| 10851695005743 | K103510 | 000 |
| 00412786063221 | K103510 | 000 |
| 24714127863065 | K103510 | 000 |
| 00851695005128 | K103510 | 000 |
| 00851695005111 | K103510 | 000 |
| 00851695005104 | K103510 | 000 |
| 00851695005098 | K103510 | 000 |
| 24714127863584 | K103510 | 000 |
| 24714127863546 | K103510 | 000 |
| 24714127863508 | K103510 | 000 |
| 24714127863478 | K103510 | 000 |
| 04714127863290 | K103510 | 000 |
| 24714127863287 | K103510 | 000 |
| 10851695005279 | K103510 | 000 |