The following data is part of a premarket notification filed by Charles L. Rose And Co., Inc. with the FDA for Unisurge Tissue Collection System For Endos Surg.
| Device ID | K914922 |
| 510k Number | K914922 |
| Device Name: | UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CHARLES L. ROSE AND CO., INC. 1963 ROCK STREET, SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose CHARLES L. ROSE AND CO., INC. 1963 ROCK STREET, SUITE 17 Mountain View, CA 94043 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-03-26 |