510(k) K014248
- Device
- DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
- Applicant
- Urogyn , Ltd.
- 510(k) number
- K014248
- Product code
- KNA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-21
- Date received
- 2001-12-26
- Regulation
- 884.4530
- Classification name
- Instrument, Manual, Specialized Obstetric-Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- EREZ ADIV
- Address
- Diamond Bldg.(26th Floor ) 3a Jabotinsky St. Ramat-Gan IL 52520 52520
FDA Registration Numbers
- 9611112
- 1825146
- 2916714
- 3009763019
- 1321175
- 3003968049
- 3010419931
- 3014926389
- 1216677
- 9612074
- 2953359
- 9710524
- 1718873
- 3032109
- 3011137372
- 9610612
- 2246552
- 3010131137
- 1219619
- 2011171
- 1820334
- 2027111
- 3014461810
- 3005987240
- 2029275
- 3009051888
- 8040233
- 3003915875
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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