FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
CARASYN HYDROGEL WOUND PRODUCTS
K Number: K961758
·
Decision Jul 11, 1996
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
15
Review Days
69
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Basic Information
- Device Name
- CARASYN HYDROGEL WOUND PRODUCTS
- K Number
- K961758
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Carrington Laboratories, Inc.
- Date Received
- May 3, 1996
- Decision Date
- July 11, 1996
- Product Code
- MGQ
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | FDA unclassified | Unknown |
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·Unknown
TENDERWET ACTIVE
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FDA Unclassified
·Unknown
Other Clearances by Carrington Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022670 | CARRAKLENZ AND ULTRAKLENZ | Oct 17, 2002 | Substantially Equivalent |
| K012126 | THE SALICEPT ORAL PATCH | Oct 3, 2001 | 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 |
| 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 |