510(k) K083721
- Device
- MODIFICATION TO ZENIEVA
- Applicant
- RIVER'S EDGE PHARMACEUTICALS, LLC
- 510(k) number
- K083721
- Product code
- NAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-08
- Date received
- 2008-12-15
- 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
- Special
- 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#
- 3015168783
- 3011987967
- 3013557562
- 3017417635
- 3016837630
- 3006802076
- 3004448390
- 3010131137
- 3011210302
- 3045742729
- 3033483207
- 3015142802
- 3043026391
- 3012852163
- 3008258694
- 3035641077
- 3004530184
- 3007327621
- 1646434
- 3027977504
- 3011715922
- 3015745029
- 3010952189
- 3006517436
- 3030067857
- 3007607706
- 3010370474
- 3008374791
- 3015172365
- 3022133572
- 2218158
- 3010132111
- 3013298431
- 3014312726
- 3009540516
- 3007841320
- 3045526618
- 3015337116
- 3008806809
- 3017633586
- 3014146451
- 9610694
- 1219103
- 3043013796
- 3017930281
- 3011862887
- 1250045
- 3003807757
- 1644312
- 9680731
- 3010288357
- 3017538679
- 3033536319
- 3005951403
- 8030128
- 8044178
- 3015140199
- 3015140210
- 3038624837
- 3010814025
- 3011529314
- 1417592
- 3032911850
- 3005621729
- 3008693666
- 2212018
- 3016615875
- 3017390965
- 3008646686
- 3012034017
- 3042276434
- 8043484
- 3042277868
- 3017210336
- 3008808082
- 1000317571
- 3016170587
- 1219592
- 3010957766
- 3034605486
Source Documents#
Other 510(k) Records For Product Code NAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082865 | MODIFICATION TO ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| K073246 | ZENIEVA | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 |
| 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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