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#
- 3012680643
- 3027617478
- 3007735241
- 3015140210
- 3030017177
- 3027341451
- 3004018264
- 3004799623
- 3015337116
- 3014146451
- 3042251637
- 3012034017
- 1000317571
- 3017210336
- 3013034812
- 3015335956
- 3009548473
- 3015172365
- 1220246
- 3013671177
- 3008258694
- 3045325156
- 3014266447
- 3017896419
- 3011529314
- 3031841433
- 3025413691
- 1038758
- 3014848316
- 3011675351
- 3008255748
- 3003887292
- 3011248038
- 3015168783
- 3012502601
- 3027605322
- 3038284048
- 3016837630
- 3031582449
- 3038356900
- 1423537
- 1219592
- 3015142802
- 3010392991
- 3011247798
- 3005343641
- 3015745029
- 3021282544
- 3027517726
- 3012084379
- 3016170587
- 3015821396
- 3007841320
- 3010814025
- 3013524663
- 3008562678
- 3015142721
- 3032911850
- 3008384335
- 3026331889
- 3011210302
- 3014897003
- 3006611176
- 9616679
- 3018101380
- 3007028032
- 3008808560
- 3007417776
- 3013530949
- 3010952189
- 3010872396
- 3013496867
- 1250045
- 1320894
- 3031092085
- 3042205143
- 3017390965
- 9681544
- 2435947
- 3010018659
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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