The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Condom.
Device ID | K940045 |
510k Number | K940045 |
Device Name: | CONDOM |
Classification | Condom |
Applicant | ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
Contact | John Moushall |
Correspondent | John Moushall ANSELL, INC. INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-05 |
Decision Date | 1995-01-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CONDOM 75282236 not registered Dead/Abandoned |
BURNS, MARVIN LOUIS 1997-04-28 |
CONDOM 75250524 2152176 Dead/Cancelled |
CHUNG CHAO CO., LTD. 1997-03-03 |
CONDOM 74049169 not registered Dead/Abandoned |
Faitel, Hubert C. 1990-04-16 |