The following data is part of a premarket notification filed by Hankook Latex Gongup Co., Ltd. with the FDA for Rubber Condom (non-colored).
| Device ID | K896987 |
| 510k Number | K896987 |
| Device Name: | RUBBER CONDOM (NON-COLORED) |
| Classification | Condom |
| Applicant | HANKOOK LATEX GONGUP CO., LTD. C.P.O. BOX 6739 Seoul, Korea, KR |
| Contact | Dukee Kwon |
| Correspondent | Dukee Kwon HANKOOK LATEX GONGUP CO., LTD. C.P.O. BOX 6739 Seoul, Korea, KR |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-13 |
| Decision Date | 1990-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851617007094 | K896987 | 000 |
| 20305369995122 | K896987 | 000 |