The following data is part of a premarket notification filed by J.k. Chemicals, Ltd. with the FDA for Latex Prophylactic Rubber Contraceptive.
Device ID | K931077 |
510k Number | K931077 |
Device Name: | LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE |
Classification | Condom |
Applicant | J.K. CHEMICALS, LTD. C/O BNF ENTERPRISES 3440 WILSHIRE BLVD., SUITE 229 Los Angeles, CA 90010 |
Contact | Chung K Kwak |
Correspondent | Chung K Kwak J.K. CHEMICALS, LTD. C/O BNF ENTERPRISES 3440 WILSHIRE BLVD., SUITE 229 Los Angeles, CA 90010 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-03 |
Decision Date | 1994-09-14 |