510(k) K091769
- Device
- TRUST DAM
- Applicant
- LINE ONE LABORATORIES, INC.
- 510(k) number
- K091769
- Product code
- MSC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-02-05
- Date received
- 2009-06-16
- Regulation
- 884.5300
- Classification name
- Barrier, Std, Oral Sex
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELI J CARTER
- Address
- P.O. Box 12139 Durham NC US 27709 27709
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 |
| K203727 | Harmony Latex Dam, Harmony Non-Latex Dam | Pamco Distributing, Inc. | 2021-08-05 |
| K990067 | SHEER GLYDE DAMS | Louise C. Myers | 1999-02-19 |
| K970577 | GLYDE DAM LOLLYES | Glyde USA, Inc. | 1998-01-08 |
Legacy Summary#
summary
FDA Review#
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