510(k) K963858
- Device
- FEMASSIST URINARY DEVICE
- Applicant
- INSIGHT MEDICAL CORP.
- 510(k) number
- K963858
- Product code
- MNG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-21
- Date received
- 1996-09-25
- Regulation
- 876.5160
- Classification name
- External Urethral Occluder, Urinary Incontinence-control, Female
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT W SCHAEFER
- Address
- 580 Main St. Bolton MA US 01740 01740
FDA Registration Numbers#
- 3016702790
- 3018269545
- 2030616
- 3023812384
- 3017654286
- 3008255748
Source Documents#
Other 510(k) Records For Product Code MNG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Personal Products Co. | 2001-04-30 |
| K983164 | RESTORE (AKA RE/STOR) | Nebl, Inc. | 1999-03-05 |
| K974600 | UROMED PATCH | Uromed Corp. | 1998-03-31 |
| K974645 | FEMASSIST FLEXIBLE | Insight Medical Corp. | 1998-02-12 |
| K971359 | RESTORE (A.K.A. CAPSURE) | Nebl, Inc. | 1997-11-14 |
| K954215 | MINIGUARD | Advanced Surgical Intervention, Inc. | 1996-05-08 |
Legacy Summary#
summary
FDA Review#
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