510(k) K965120
- Device
- ALLCLENZ WOUND CLEANSER
- Applicant
- DPT LABORATORIES, LTD.
- 510(k) number
- K965120
- Product code
- KMF
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1997-03-21
- Date received
- 1996-12-23
- Regulation
- 880.5090
- Classification name
- Bandage, Liquid
- Medical specialty
- General Hospital
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- 100 E. 15th St.,Suite 320 Fort Worth TX US 76102 76102
FDA Registration Numbers#
- 9617175
- 1423537
- 8043396
- 3010034760
- 3010131715
- 2029275
- 3011987967
- 3003636207
- 3007289408
- 3031841433
- 3007663067
- 3036497156
- 1649690
- 1018120
- 1047843
- 1419520
- 1054241
- 1067168
- 1018470
- 3013188547
- 1220477
- 3003559457
- 1130591
- 1121142
- 1921846
- 1055236
- 3004111573
- 1649518
- 2245437
- 1061124
- 3008719017
- 9680091
- 3016678045
- 3012669304
- 3030733800
- 1043214
- 3002371949
- 9615414
- 3002807310
- 3010034780
- 3003744503
- 3013298431
- 3006385287
- 2434982
- 1417592
- 3008132398
- 3014637532
- 3010132111
- 3005941719
- 3007735241
- 3042272797
- 2320961
- 1647149
- 3016761372
- 3012494290
- 1480288
- 3009609358
- 3021784063
- 8043484
- 2183744
- 3016265529
- 1063707
- 1058584
- 3004402508
- 9681465
- 3004512585
- 2438948
- 3006218807
- 3031757047
- 3030446844
- 3014579161
- 1628114
- 1225598
- 2242239
- 3012421607
- 9614493
- 3013557562
- 3005427465
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin Protectant | Optmed, Inc. | 2024-09-27 |
| K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | 2019-06-27 |
| K171148 | Aleo BME Liquid Bandage | Aleo Bme, Inc. | 2018-01-12 |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | 3M Healthcare | 2016-08-23 |
| K160684 | Atteris No-Sting Skin Protectant | Rochal Industries, LLC | 2016-07-26 |
| K131384 | KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE | Kericure, Inc. | 2014-08-07 |
| K133443 | MARATHON NO STING LIQUID SKIN PROTECTANT | Advanced Medical Solutions (Plymouth), Ltd. | 2014-07-10 |
| K120059 | LIQUID BANDAGE | Chesson Laboratory Associates, Inc. | 2012-05-17 |
| K092712 | SKIN BARRIER FILM | Lodestar Products, Inc. | 2010-02-23 |
| K083087 | ECOCEL | Polichem S.A | 2009-08-07 |
| K083913 | CHESSON LABS LIQUID BANDAGE | Chesson Laboratory Associates, Inc. | 2009-07-31 |
| K083752 | GLUSEAL 90, MODEL GLU9010 | Glustitch, Inc. | 2009-02-23 |
| K082703 | MRDH BANDAGE | Marine Polymer Technologies, Inc. | 2008-10-14 |
| K081009 | NEUTROPHASE | Novabay Pharmaceuticals | 2008-05-20 |
| K073663 | GELSPRAY WOUND DRESSING | Biocure, Inc. | 2008-01-30 |
Legacy Summary#
summary
FDA Review#
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