FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
THE SALICEPT ORAL PATCH
K Number: K012126
·
Decision Oct 3, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
40
Applicant Total
15
Review Days
89
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Basic Information
- Device Name
- THE SALICEPT ORAL PATCH
- K Number
- K012126
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carrington Laboratories, Inc.
- Date Received
- July 6, 2001
- Decision Date
- October 3, 2001
- Product Code
- OLR
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLR | Oral Wound Dressing | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLR), ordered by most recent decision date.
Curajel Oral Gel
FDA 510(k)
FDA Unclassified
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MuCover (proposed name) Oral Wound Dressing
FDA 510(k)
FDA Unclassified
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Dental Cone; Dental Sponge
FDA 510(k)
FDA Unclassified
·Unknown
Silatrix Oral Gel
FDA 510(k)
FDA Unclassified
·Unknown
Elemental Granulate
FDA 510(k)
FDA Unclassified
·Unknown
HealiAid Dental Collagen Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Carrington Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022670 | CARRAKLENZ AND ULTRAKLENZ | Oct 17, 2002 | Substantially Equivalent |
| K983182 | ALOE THERAPY ORAL RINSE | Dec 10, 1998 | Substantially Equivalent |
| K964852 | RADIACARE ORAL WOUND RINSE | Mar 3, 1997 | Substantially Equivalent |
| K962218 | CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG | Sep 12, 1996 | Substantially Equivalent for Some Indications |
| K961758 | CARASYN HYDROGEL WOUND PRODUCTS | Jul 11, 1996 | Substantially Equivalent for Some Indications |
| K960428 | CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION) | Mar 21, 1996 | Substantially Equivalent for Some Indications |
| K953423 | CASRRASYN ORAL WOUND DRESSING | Oct 11, 1995 | Substantially Equivalent |
| K951417 | CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS | May 10, 1995 | Substantially Equivalent |
| K944427 | CARRASYN FDG | Nov 29, 1994 | Substantially Equivalent for Some Indications |
| K933741 | CARRASYN ORAL WOUND DRESSING | May 4, 1994 | Substantially Equivalent for Some Indications |