The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Thermique.
Device ID | K022097 |
510k Number | K022097 |
Device Name: | THERMIQUE |
Classification | Tester, Pulp |
Applicant | PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
Contact | Daniel R Schechter |
Correspondent | Daniel R Schechter PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
Product Code | EAT |
CFR Regulation Number | 872.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-06-27 |
Decision Date | 2002-09-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMIQUE 73551083 1384419 Dead/Cancelled |
ARIS ISOTONER GLOVES, INC. 1985-07-31 |
THERMIQUE 73350793 1257601 Dead/Cancelled |
Corning Designs, Ltd. 1982-02-18 |
THERMIQUE 73223015 1203550 Dead/Cancelled |
Phenol Insulation Products Inc. 1979-07-12 |