510(k) K073246
- Device
- ZENIEVA
- Applicant
- GORBEC PHARMACEUTICAL SERVICES, INC.
- 510(k) number
- K073246
- Product code
- NAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-23
- Date received
- 2007-11-19
- Regulation
- 878.4022
- Classification name
- Dressing, Wound, Hydrogel Without Drug And/or Biologic
- 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
- SANDRA R KIRCUS
- Address
- 2445 S. Alston Ave. Durham NC US 27713 27713
FDA Registration Numbers#
- 3010131137
- 3012421607
- 3015821396
- 1648579
- 3010934856
- 3013671177
- 3016837630
- 3038220293
- 3012907824
- 3007307589
- 3010155661
- 3010035774
- 3045058049
- 8043484
- 3015414875
- 3031184338
- 3026263452
- 1526534
- 3010872396
- 3012311599
- 3012777736
- 3021033324
- 3006788879
- 3017910381
- 3007766648
- 3013496867
- 3009167225
- 9680731
- 1480288
- 3025413691
- 3036933864
- 3008261762
- 3021282544
- 3044150131
- 3007735241
- 3015337116
- 3022754162
- 8044178
- 1646434
- 3014848316
- 1220246
- 3030226294
- 3003887292
- 3007417776
- 3011983031
- 3043012215
- 9681630
- 2954718
- 3031582434
- 3010370474
- 1226486
- 3011529314
- 3008808560
- 9710020
- 3012706495
- 1038758
- 1250045
- 1036836
- 3010198795
- 2530957
- 3043105506
- 3010957766
- 3013298431
- 3006784948
- 3038284048
- 3027977504
- 3003866267
- 3016758972
- 1054811
- 3012034017
- 3008255748
- 3006611176
- 3044026004
- 1417592
- 3008132238
- 3014897003
- 3015172365
- 3017417635
- 3033483207
Source Documents#
Other 510(k) Records For Product Code NAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K083721 | MODIFICATION TO ZENIEVA | River'S Edge Pharmaceuticals, LLC | 2009-01-08 |
| K082865 | MODIFICATION TO ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| K992094 | GILTECH PLUS HYDROGEL SKIN DRESSING | Giltech Plus, Inc. | 1999-09-17 |
| K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | 1999-06-28 |
| K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | Ludlow Technical Products | 1997-08-21 |
| K971597 | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | Coloplast Corp. | 1997-07-29 |
| K962352 | HYDROGEL SKIN DRESSING | North American Sterilization & Packaging Co. | 1996-08-02 |
| K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | Sherwood Medical Co. | 1995-08-23 |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Bioderm, Inc. | 1995-06-21 |
| K950412 | CURAGEL HYDROGEL WOUND DRESSING | Kendall Healthcare Products Co. Div.Of Tyco Health | 1995-03-24 |
| K945832 | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS | Brady Medical Products Co. | 1995-03-01 |
| K942748 | INTRASITE | Smith & Nephew United, Inc. | 1994-06-29 |
| K941019 | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING | Brady Medical Products Co. | 1994-05-04 |
| K934601 | NDM HYDROGAUZE WOUND DRESSING | Ndm Acquisition Corp. | 1994-02-15 |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | Smith & Nephew United, Inc. | 1994-02-15 |
Legacy Summary#
summary
FDA Review#
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