The following data is part of a premarket notification filed by Pamco Distributing Inc. with the FDA for Harmony Latex Dam, Harmony Non-latex Dam.
| Device ID | K203727 |
| 510k Number | K203727 |
| Device Name: | Harmony Latex Dam, Harmony Non-Latex Dam |
| Classification | Barrier, Std, Oral Sex |
| Applicant | Pamco Distributing Inc. 231 Arnold Street Kitchener, CA N2h 6e8 |
| Contact | Annette Maclean |
| Correspondent | Catriona Boyd Ironstone Product Development 250 Carlaw Avenue, Suite 108 Toronto, CA M4m 3l1 |
| Product Code | MSC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003804537 | K203727 | 000 |
| 00860003804520 | K203727 | 000 |
| 00860003804513 | K203727 | 000 |
| 00860003804544 | K203727 | 000 |
| 00628347069810 | K203727 | 000 |
| 00628347065881 | K203727 | 000 |
| 00628347062729 | K203727 | 000 |