DECALCIFYING SOLUTION II
FDA 510(k) clearance K881359 · decided 1988-04-19
Clearance details
- K-number
- K881359
- Device name
- DECALCIFYING SOLUTION II
- Applicant
- Stephens Scientific
- Decision
- Substantially Equivalent
- Date received
- 1988-03-31
- Decision date
- 1988-04-19
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- KOX
- Device class
- 1
- Regulation number
- 878.4730
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Denville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| SEPP ADHESIVE REMOVER (K934790) | Medi-Flex Hospital Products, Inc. | 1994-03-11 |
| CHAD LABS ADHESIVE BANDAGE REMOVER (K931933) | Chad Labs Corp. | 1993-07-08 |
| ALLKARE(TM) ADHESIVE REMOVER WIPE (K924976) | Convatec, A Division of E.R. Squibb & Sons | 1993-04-20 |
| MEDI-SOL (K924571) | Orange-Sol, Inc. | 1993-04-06 |
| 3M REMOVER LOTION PRODUCT NUMBER 86XX (K925618) | 3M Health Care, Ltd. | 1993-03-31 |
| SKIN SUPPORT PREP PAD (K923351) | Coloplast Corp. | 1992-09-14 |
| REMOVE ADHESIVE REMOVER (K915150) | Smith & Nephew United, Inc. | 1992-01-09 |
| ELANTEC'S SURGICAL TAPE REMOVER (K902009) | Elantec, Inc. | 1990-08-29 |
| KEMI LABS - ADHESIVE BANDAGE REMOVER (K895293) | Kemi Labs, Inc. | 1990-02-09 |
| REMOVE ADHESIVE REMOVER (K893603) | Smith & Nephew United, Inc. | 1989-07-14 |
| ADHESIVE REMOVER (K821162) | The Healthcare Group Laboratories, Inc. | 1982-05-14 |
Recalls involving this device
No recalls on record reference this clearance.