510(k) K110355
- Device
- VENX REVOLUTION
- Applicant
- VENX LLC
- 510(k) number
- K110355
- Product code
- GAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-04-22
- Date received
- 2011-02-07
- Regulation
- 878.4800
- Classification name
- Stylet, Surgical, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- IRA DUESLER
- Address
- 4700 S. Overland Dr. Tucson AZ US 85714 85714
FDA Registration Numbers#
- 9611112
- 8010372
- 3004215117
- 2249529
- 8010282
- 3015967359
- 1421879
- 3013666218
- 3007344102
- 8040278
- 3010041511
- 1923569
- 9611827
- 3007156625
- 2183449
- 3015212339
- 3012536737
- 2030624
- 3033589330
- 3008850074
- 3009255580
- 8031020
- 1221435
- 9616662
- 3007456622
- 1836161
- 3015309643
- 3002250546
- 3026297283
- 3013156185
- 3031231776
- 9680837
- 2529846
- 3003828812
- 3013540005
- 8044098
- 1820334
- 3033509898
- 3003418325
- 3005596514
- 3033536312
- 3007125392
- 3015925358
- 3011137372
- 1646747
- 3010202439
- 3002807314
- 3008102049
- 3014023545
- 8040233
- 3009417901
- 3006460162
- 1216677
- 8010300
- 3004049923
- 3006897996
- 1721504
- 9610612
- 3006950086
- 3014334038
- 3011371465
- 3005809810
- 9710524
- 3004371426
- 2020550
- 3043007473
- 3009540749
- 9611610
- 3012185136
- 3008902714
- 3014170143
- 1835572
- 3008770252
- 3010673850
- 3021477808
- 1000393132
- 1723170
- 3038187464
- 1220477
- 3018094310
Source Documents#
Other 510(k) Records For Product Code GAH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000932 | ARACHNOPHLEBECTOMY NEEDLE | Advanced Medical Products, Inc. | 2000-05-17 |
| K970306 | MARKMAN TEMPLATE SYSTEM | Barry Markman, M.D. | 1997-11-20 |
| K972918 | RAPID FIRE HAIR IMPLANTER CAROUSEL | Apex Medical Products, LLC | 1997-10-27 |
| K972521 | NAVIGATOR (STYLET) 2006 | Sil-Med Corp. | 1997-10-01 |
| K952737 | CALVITRON HAIR TRANSPLANT SYSTEM | Medicamat S.A. | 1995-10-03 |
| K770970 | HAIR TRANSPLANT PUNCH, MULTIPLH | Padgett Instruments, Inc. | 1977-10-27 |
Legacy Summary#
summary
FDA Review#
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