The following data is part of a premarket notification filed by Sagami, Inc. with the FDA for Condoms (multiple Brands).
| Device ID | K897129 |
| 510k Number | K897129 |
| Device Name: | CONDOMS (MULTIPLE BRANDS) |
| Classification | Condom |
| Applicant | SAGAMI, INC. 8725 WEST HIGGINS RD. SUITE 481 Chicago, IL 60631 |
| Contact | Tim Weaver |
| Correspondent | Tim Weaver SAGAMI, INC. 8725 WEST HIGGINS RD. SUITE 481 Chicago, IL 60631 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10019283927581 | K897129 | 000 |
| 10019283923323 | K897129 | 000 |
| 10019283923279 | K897129 | 000 |
| 00850002174298 | K897129 | 000 |
| 00850002174281 | K897129 | 000 |