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#
- 3010700223
- 3012940386
- 3008261762
- 3016807311
- 3014570707
- 3008806809
- 3016746332
- 1250045
- 3013557562
- 3012852163
- 3016170587
- 3038356900
- 9680091
- 2518467
- 3021282544
- 3032911850
- 3008646686
- 3006784948
- 3015745029
- 3031841433
- 3007124979
- 3010035774
- 3010934856
- 3008044603
- 3007187674
- 3008562678
- 3038310422
- 3004957256
- 3008427684
- 1219103
- 3004799623
- 2218158
- 3016758972
- 3009134882
- 1417592
- 3012777736
- 3013226
- 3015337116
- 3004018264
- 3003676119
- 3015414875
- 3010872396
- 1423537
- 3012680643
- 3030017177
- 3005621729
- 3038624837
- 3035641077
- 3017297225
- 3012311599
- 3042272797
- 2110420
- 3010155661
- 3013530901
- 3006358042
- 3011814545
- 3016615875
- 3007327621
- 3041329419
- 3010018659
- 3015142721
- 3031582449
- 2954718
- 9614157
- 3003866267
- 3026263452
- 3008174904
- 3023339256
- 3044150131
- 3017930281
- 3013632692
- 3012907824
- 3038284048
- 3006517436
- 9680731
- 3013957847
- 9616679
- 3003175285
- 3008693666
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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