The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Am-pak.
Device ID | K912436 |
510k Number | K912436 |
Device Name: | AM-PAK |
Classification | Amplifier, Physiological Signal |
Applicant | CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
Contact | John F Stolte |
Correspondent | John F Stolte CNS, INC. 1250 PARK RD. Chanhassen, MN 55317 |
Product Code | GWL |
CFR Regulation Number | 882.1835 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-03 |
Decision Date | 1991-10-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AM-PAK 73588605 not registered Dead/Abandoned |
NATURE'S WAY PRODUCTS, INC. 1986-03-17 |
AM-PAK 73295774 not registered Dead/Abandoned |
BEECHAM INC. 1981-02-05 |
AM-PAK 73143927 1090263 Dead/Expired |
AMERICAN AIR FILTER COMPANY, INC. 1977-10-06 |