The following data is part of a premarket notification filed by Paraworks Enterprise, Ltd. with the FDA for A P Harness.
| Device ID | K981860 |
| 510k Number | K981860 |
| Device Name: | A P HARNESS |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | PARAWORKS ENTERPRISE, LTD. #1-179 WEST 17TH AVENUE Vancouver, British Columbia, CA V57 1z7 |
| Contact | Michael C Campbell |
| Correspondent | Michael C Campbell PARAWORKS ENTERPRISE, LTD. #1-179 WEST 17TH AVENUE Vancouver, British Columbia, CA V57 1z7 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-27 |
| Decision Date | 1999-06-03 |
| Summary: | summary |