The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Coopersurgical Model 6080 Smoke Evacuator System.
| Device ID | K910377 |
| 510k Number | K910377 |
| Device Name: | COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937019940 | K910377 | 000 |
| 00888937014440 | K910377 | 000 |
| 00888937014327 | K910377 | 000 |
| 00888937014242 | K910377 | 000 |
| 20888937000058 | K910377 | 000 |
| 00888937026597 | K910377 | 000 |