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 |
00628347062774 | K203727 | 000 |
00628347062736 | K203727 | 000 |