The following data is part of a premarket notification filed by Iris Medical Ent., Inc. with the FDA for Condom.
| Device ID | K881735 |
| 510k Number | K881735 |
| Device Name: | CONDOM |
| Classification | Condom |
| Applicant | IRIS MEDICAL ENT., INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Leslie Kux |
| Correspondent | Leslie Kux IRIS MEDICAL ENT., INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-22 |
| Decision Date | 1988-07-05 |
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 |