FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR EVACARE VAGINAL PESSARIES
K Number: K993308
·
Decision Dec 13, 1999
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
61
Review Days
70
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Basic Information
- Device Name
- MENTOR EVACARE VAGINAL PESSARIES
- K Number
- K993308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3575
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Corp.
- Date Received
- October 4, 1999
- Decision Date
- December 13, 1999
- Product Code
- HHW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HHW | Pessary, Vaginal | FDA class 2 | Obstetrics/Gynecology |
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|---|---|---|---|
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| K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | Jun 3, 2005 | Substantially Equivalent |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | Nov 9, 2004 | Substantially Equivalent |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Oct 29, 2004 | Substantially Equivalent |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | Jul 17, 2003 | Substantially Equivalent |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Oct 1, 2002 | Substantially Equivalent |
| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | Dec 3, 2001 | Substantially Equivalent |
| K004005 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) | Oct 12, 2001 | Substantially Equivalent |
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | Apr 23, 2001 | Substantially Equivalent |