510(k) K923351
- Device
- SKIN SUPPORT PREP PAD
- Applicant
- COLOPLAST CORP.
- 510(k) number
- K923351
- Product code
- KOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-09-14
- Date received
- 1992-07-08
- Regulation
- 878.4730
- Classification name
- Solvent, Adhesive Tape
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEE LEWIS
- Address
- 2150 New Market Pkwy., Suite 116 Marietta GA US 30067 30067
FDA Registration Numbers#
- 3013473968
- 8022978
- 3004777506
- 1319744
- 2320961
- 1250045
- 3003559457
- 3010951382
- 3008806809
- 3033519
- 3017189082
- 1063707
- 3023471
- 1922337
- 3024808683
- 1450386
- 3014663650
- 3010034780
- 2320762
- 3004512585
- 3041329419
- 9616572
- 3010657142
- 3009167225
- 3008374791
- 3042283853
- 1519375
- 3016756928
- 3042024535
- 3006580788
- 2417346
- 3012034017
- 3010951384
- 2411192
- 3016426850
- 3011987967
- 1413547
- 2183164
- 2244725
- 9610694
- 3010952189
- 3011191255
- 3036978602
- 1043214
- 3008298053
- 3014146451
- 3012421607
- 3003887639
- 3015058854
- 3024491894
- 2518467
- 3015337116
- 3030733800
- 1921846
- 3014672091
- 8032044
- 9616874
- 3008262278
- 3010339057
- 3011689956
- 3010605379
- 3011983031
- 3004472810
- 8043484
- 3010034760
- 3008132238
- 3023464160
- 3006542993
- 1018120
- 3031841433
- 9681702
- 3012910884
- 3014421917
- 3006371704
- 3013863160
- 2246552
- 3030067857
- 1423537
- 3010872396
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934790 | SEPP ADHESIVE REMOVER | Medi-Flex Hospital Products, Inc. | 1994-03-11 |
| K931933 | CHAD LABS ADHESIVE BANDAGE REMOVER | Chad Labs Corp. | 1993-07-08 |
| K924976 | ALLKARE(TM) ADHESIVE REMOVER WIPE | Convatec, A Division of E.R. Squibb & Sons | 1993-04-20 |
| K924571 | MEDI-SOL | Orange-Sol, Inc. | 1993-04-06 |
| K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX | 3M Health Care, Ltd. | 1993-03-31 |
| K915150 | REMOVE ADHESIVE REMOVER | Smith & Nephew United, Inc. | 1992-01-09 |
| K902009 | ELANTEC'S SURGICAL TAPE REMOVER | Elantec, Inc. | 1990-08-29 |
| K895293 | KEMI LABS - ADHESIVE BANDAGE REMOVER | Kemi Labs, Inc. | 1990-02-09 |
| K893603 | REMOVE ADHESIVE REMOVER | Smith & Nephew United, Inc. | 1989-07-14 |
| K881359 | DECALCIFYING SOLUTION II | Stephens Scientific | 1988-04-19 |
| K821162 | ADHESIVE REMOVER | The Healthcare Group Laboratories, Inc. | 1982-05-14 |
Legacy Summary#
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FDA Review#
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