Harmony Latex Dam, Harmony Non-Latex Dam
FDA 510(k) clearance K203727 · decided 2021-08-05
Clearance details
- K-number
- K203727
- Device name
- Harmony Latex Dam, Harmony Non-Latex Dam
- Applicant
- Pamco Distributing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-21
- Decision date
- 2021-08-05
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- MSC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Kitchener, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pamco Distributing
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIXI (LXOSFM1) (K253662) | Luwi, LLC | 2026-07-14 |
| Lorals (K212928) | Brazen Goods Inc. Dba Lorals | 2022-04-22 |
| SancDam Latex Oral Dam (K212037) | Sanctuary Health Sdn. Bhd. | 2022-03-28 |
| TRUST DAM (K091769) | Line One Laboratories, Inc. | 2010-02-05 |
| SHEER GLYDE DAMS (K990067) | Louise C. Myers | 1999-02-19 |
| GLYDE DAM LOLLYES (K970577) | Glyde USA, Inc. | 1998-01-08 |
Recalls involving this device
No recalls on record reference this clearance.