The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Magnum Plus Latex Condom W/spermicidal Lubricant.
| Device ID | K895640 |
| 510k Number | K895640 |
| Device Name: | MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT |
| Classification | Condom |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Stephen Kolakowsky |
| Correspondent | Stephen Kolakowsky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-19 |
| Decision Date | 1990-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813356000132 | K895640 | 000 |
| 80022600001405 | K895640 | 000 |
| 00022600646037 | K895640 | 000 |
| 00022600642039 | K895640 | 000 |