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 |