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 |