The following data is part of a premarket notification filed by Care Products, Inc. with the FDA for Coloncare.
Device ID | K030216 |
510k Number | K030216 |
Device Name: | COLONCARE |
Classification | Reagent, Occult Blood |
Applicant | CARE PRODUCTS, INC. 231 BANK STREET SUITE 203 Waterbury, CT 06702 |
Contact | Hubert Pototschnig |
Correspondent | Hubert Pototschnig CARE PRODUCTS, INC. 231 BANK STREET SUITE 203 Waterbury, CT 06702 |
Product Code | KHE |
CFR Regulation Number | 864.6550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-21 |
Decision Date | 2003-04-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() COLONCARE 78304536 not registered Dead/Abandoned |
Scheuringer, Kim, J 2003-09-24 |