510(k) K993653
- Device
- MICRO-FRANCE TROCARS AND ACCESSORIES
- Applicant
- XOMED, INC.
- 510(k) number
- K993653
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-06-09
- Date received
- 1999-10-29
- Regulation
- 884.1720
- Classification name
- Laparoscope, Gynecologic (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- MARTIN D SARGENT
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3002808148
- 1423662
- 3007789561
- 1057358
- 1825146
- 3019783123
- 1412854
- 9680515
- 1061124
- 3002807315
- 3012507533
- 9614969
- 3008693678
- 3015540957
- 3006546082
- 1018470
- 1216677
- 9612074
- 3025482817
- 3003724334
- 3012460907
- 2032521
- 1720747
- 2649614
- 3008132398
- 3001556604
- 1643264
- 3011050570
- 9610612
- 3010202439
- 3015219237
- 8044098
- 1820334
- 1218882
- 8010877
- 8010298
- 8010487
- 3017636737
- 3021839632
- 1418479
- 9611612
- 2916714
- 8010510
- 3004361445
- 1483278
- 8043746
- 1519132
- 1043214
- 3006554912
- 1055236
- 3014279513
- 3010155661
- 1649518
- 1058584
- 8043903
- 3027454635
- 3009217531
- 3007421149
- 9611503
- 3006787036
- 3011986317
- 1035968
- 3009134855
- 2936485
- 3033043422
- 3014342096
- 3006897899
- 1319639
- 9680837
- 8010418
- 3008044552
- 3012322232
- 9611102
- 3009763019
- 2648623
- 3004491689
- 3013011598
- 9615001
- 3008102042
- 3008386005
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| 10381780095453 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780095170 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780095187 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780095194 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780095200 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780096788 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780096764 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
| 10381780096641 | Integra® MicroFrance® | INTEGRA MICROFRANCE | 2016-09-22 |
Legacy Summary
summary
FDA Review
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