510(k) K203727
- Device
- Harmony Latex Dam, Harmony Non-Latex Dam
- Applicant
- Pamco Distributing Inc.
- 510(k) number
- K203727
- Product code
- MSC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-05
- Date received
- 2020-12-21
- Regulation
- 884.5300
- Classification name
- Barrier, Std, Oral Sex
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Annette Maclean
- Address
- 231 Arnold St. Kitchener CA N2H 6E8 N2H 6E8
FDA Registration Numbers#
- 8021853
- 3007829481
- 1222115
- 9680135
- 3005497907
Source Documents#
Other 510(k) Records For Product Code MSC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022-04-22 |
| K212037 | SancDam Latex Oral Dam | Sanctuary Health Sdn. Bhd. | 2022-03-28 |
| K091769 | TRUST DAM | Line One Laboratories, Inc. | 2010-02-05 |
| K990067 | SHEER GLYDE DAMS | Louise C. Myers | 1999-02-19 |
| K970577 | GLYDE DAM LOLLYES | Glyde USA, Inc. | 1998-01-08 |
Legacy Summary#
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FDA Review#
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