The following data is part of a premarket notification filed by Evans Medical, Inc. with the FDA for Evans Medical Extension Sets.
| Device ID | K935642 |
| 510k Number | K935642 |
| Device Name: | EVANS MEDICAL EXTENSION SETS |
| Classification | Tubing, Fluid Delivery |
| Applicant | EVANS MEDICAL, INC. 2976 WINDY BUSH RD. P.O. BOX 326 Pineville, PA 18946 |
| Contact | David W Evans |
| Correspondent | David W Evans EVANS MEDICAL, INC. 2976 WINDY BUSH RD. P.O. BOX 326 Pineville, PA 18946 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-22 |
| Decision Date | 1994-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817708020267 | K935642 | 000 |
| 00817708020045 | K935642 | 000 |
| 00817708020069 | K935642 | 000 |
| 00817708020083 | K935642 | 000 |
| 00817708020106 | K935642 | 000 |
| 00817708020120 | K935642 | 000 |
| 00817708020144 | K935642 | 000 |
| 00817708020168 | K935642 | 000 |
| 00817708020182 | K935642 | 000 |
| 00817708020205 | K935642 | 000 |
| 00817708020229 | K935642 | 000 |
| 00817708020243 | K935642 | 000 |
| 00817708020021 | K935642 | 000 |