The following data is part of a premarket notification filed by Fortune Medical Instrument Corp. with the FDA for All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes And Cwv Reservoir.
| Device ID | K980917 |
| 510k Number | K980917 |
| Device Name: | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas FORTUNE MEDICAL INSTRUMENT CORP. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-11 |
| Decision Date | 1998-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711182613051 | K980917 | 000 |
| 04710961934356 | K980917 | 000 |
| 04710961934363 | K980917 | 000 |
| 04710961934370 | K980917 | 000 |
| 04710961934387 | K980917 | 000 |
| 04710961934394 | K980917 | 000 |
| 04710961934400 | K980917 | 000 |
| 04710961934417 | K980917 | 000 |
| 04710961934424 | K980917 | 000 |
| 04710961934349 | K980917 | 000 |
| 04710961934332 | K980917 | 000 |
| 14711182608313 | K980917 | 000 |
| 04710961934264 | K980917 | 000 |
| 04710961934271 | K980917 | 000 |
| 04710961934288 | K980917 | 000 |
| 04710961934295 | K980917 | 000 |
| 04710961934301 | K980917 | 000 |
| 04710961934318 | K980917 | 000 |
| 04710961934325 | K980917 | 000 |
| 04710961934431 | K980917 | 000 |
| 04710961934448 | K980917 | 000 |
| 04711182607548 | K980917 | 000 |
| 04711182609238 | K980917 | 000 |
| 04711182612993 | K980917 | 000 |
| 04711182613006 | K980917 | 000 |
| 04711182613013 | K980917 | 000 |
| 04711182613020 | K980917 | 000 |
| 04711182613037 | K980917 | 000 |
| 04711182613044 | K980917 | 000 |
| 04711182607432 | K980917 | 000 |
| 04711182607425 | K980917 | 000 |
| 04710961934455 | K980917 | 000 |
| 04710961934462 | K980917 | 000 |
| 04710961934479 | K980917 | 000 |
| 04710961934486 | K980917 | 000 |
| 04711182606428 | K980917 | 000 |
| 04711182606435 | K980917 | 000 |
| 04711182607401 | K980917 | 000 |
| 04711182607418 | K980917 | 000 |
| 14711182608306 | K980917 | 000 |