The following data is part of a premarket notification filed by Chester Labs, Inc. with the FDA for E-z Lubricating Jelly.
Device ID | K041060 |
510k Number | K041060 |
Device Name: | E-Z LUBRICATING JELLY |
Classification | Lubricant, Patient |
Applicant | CHESTER LABS, INC. 1900 SECTION RD. Cincinnati, OH 45237 |
Contact | John B Armstrong |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | KMJ |
CFR Regulation Number | 880.6375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-04-23 |
Decision Date | 2004-05-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
E-Z LUBRICATING JELLY 97177666 not registered Live/Pending |
Athena Medical Products, Inc. 2021-12-17 |
E-Z LUBRICATING JELLY 75117005 2141457 Live/Registered |
CHESTER PACKAGING, LLC 1996-06-10 |