The following data is part of a premarket notification filed by Poly Medical Technologies, Inc. with the FDA for Polypole.
| Device ID | K861838 |
| 510k Number | K861838 |
| Device Name: | POLYPOLE |
| Classification | Stand, Infusion |
| Applicant | POLY MEDICAL TECHNOLOGIES, INC. 17995 HIGHLAND AVE. Deephaven, MN 55391 |
| Contact | William G Lafferty |
| Correspondent | William G Lafferty POLY MEDICAL TECHNOLOGIES, INC. 17995 HIGHLAND AVE. Deephaven, MN 55391 |
| Product Code | FOX |
| CFR Regulation Number | 880.6990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-13 |
| Decision Date | 1986-06-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() POLYPOLE 74380661 1826379 Dead/Cancelled |
Capps' Customs 1993-04-20 |