The following data is part of a premarket notification filed by Green Cross Medical Supplies Corp. with the FDA for Aegis(tm) Condoms.
| Device ID | K883409 |
| 510k Number | K883409 |
| Device Name: | AEGIS(TM) CONDOMS |
| Classification | Condom |
| Applicant | GREEN CROSS MEDICAL SUPPLIES CORP. 1443-10 SEOCHO-DONG, SEOCHO- KU Seoul, KR |
| Contact | Hoon Kim |
| Correspondent | Hoon Kim GREEN CROSS MEDICAL SUPPLIES CORP. 1443-10 SEOCHO-DONG, SEOCHO- KU Seoul, KR |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1989-03-13 |