FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
XEROFORM DRESSING
K Number: K813535
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
7
Review Days
49
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Basic Information
- Device Name
- XEROFORM DRESSING
- K Number
- K813535
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- W.G. Whitney Corp.
- Date Received
- December 17, 1981
- Decision Date
- February 4, 1982
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by W.G. Whitney Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K834532 | STERILE WET DRESSING PACK | Jan 25, 1984 | Substantially Equivalent |
| K810406 | STERILE WET DRESSING PACK | Mar 11, 1981 | Substantially Equivalent |
| K803299 | COLD/HOT PACK | Jan 15, 1981 | Substantially Equivalent |
| K800907 | TOMAC WET DRESSING WARMER | May 20, 1980 | Substantially Equivalent |
| K781322 | STERILE WET DRESSING PACK | Aug 17, 1978 | Substantially Equivalent |
| K770387 | UNICATCH | Apr 5, 1977 | Substantially Equivalent |