510(k) K881359
- Device
- DECALCIFYING SOLUTION II
- Applicant
- STEPHENS SCIENTIFIC
- 510(k) number
- K881359
- Product code
- KOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-19
- Date received
- 1988-03-31
- Regulation
- 878.4730
- Classification name
- Solvent, Adhesive Tape
- Medical specialty
- General & Plastic Surgery
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES D YEAKEL
- Address
- 7 Astro Pl., P.O. Box 1116 Denville NJ US 07834 07834
FDA Registration Numbers#
- 3004472810
- 3014404707
- 1423537
- 3010034760
- 3011987967
- 2411192
- 3013863160
- 2244725
- 3014672091
- 3006897996
- 3031841433
- 8022978
- 2183164
- 1811212
- 3012910884
- 9616572
- 3003622638
- 3042283853
- 1649690
- 3006542993
- 1018120
- 3030067857
- 3023471
- 3016452400
- 3012034017
- 3006580788
- 3003617485
- 3008374791
- 1922337
- 3036978602
- 3010605379
- 3003559457
- 1413547
- 1921846
- 3033519
- 3042024535
- 3010951382
- 1519375
- 3008806809
- 3003887639
- 3008132238
- 3015337116
- 3004777506
- 1319744
- 3006371704
- 3030733800
- 2320762
- 1043214
- 2246552
- 3010657142
- 3009840221
- 3014146451
- 3010623099
- 3005528784
- 3010034780
- 3016756928
- 3013298431
- 3023464160
- 8032044
- 1250045
- 3011983031
- 3015058854
- 3014663650
- 9610694
- 2023344
- 3011191255
- 2320961
- 3012494290
- 3022320321
- 3024491894
- 1480288
- 3017189082
- 3010952189
- 2417346
- 3010951384
- 9681702
- 3024808683
- 8043484
- 3016426850
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 |
| K923351 | SKIN SUPPORT PREP PAD | Coloplast Corp. | 1992-09-14 |
| 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 |
| K821162 | ADHESIVE REMOVER | The Healthcare Group Laboratories, Inc. | 1982-05-14 |
Legacy Summary#
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FDA Review#
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