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#
- 3007417776
- 1648579
- 3005951403
- 3006517436
- 3033483207
- 3015414875
- 3036933864
- 3010872396
- 3017297225
- 3008979241
- 3009482034
- 3011675351
- 3003965134
- 3007307589
- 3017390965
- 3045058049
- 3007327621
- 3003676119
- 3017210336
- 3014146451
- 3013595964
- 1250045
- 3043105506
- 3008044603
- 3013530949
- 3013226
- 3036035308
- 1320894
- 3017417635
- 3017930281
- 3014570707
- 3043026391
- 2435947
- 9616679
- 3018101380
- 3012421607
- 1423537
- 3008808082
- 3004799623
- 3016615875
- 3010934856
- 1063707
- 2135152
- 3015745029
- 3015168783
- 3008255748
- 3042283853
- 3008562678
- 3042972928
- 1649518
- 3011191255
- 3007841320
- 3014848316
- 3005621729
- 8030128
- 3011248038
- 3013530901
- 2530957
- 3021033324
- 3014897003
- 3027517726
- 3006621348
- 3006802076
- 3010018659
- 3015337116
- 3038310422
- 1223925
- 3006358042
- 8044178
- 3026331889
- 3008045828
- 3007594734
- 3008384335
- 3015335956
- 2435946
- 3010951384
- 3013632692
- 3035641077
- 3008244559
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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