FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNICATCH
K Number: K770387
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
294
Registration Numbers
294
Same Product Code
22
Applicant Total
7
Review Days
36
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Basic Information
- Device Name
- UNICATCH
- K Number
- K770387
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- W.G. Whitney Corp.
- Date Received
- February 28, 1977
- Decision Date
- April 5, 1977
- Product Code
- FMH
- Advisory Committee
- Pathology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMH | Container, Specimen, Sterile | FDA class 1 | Pathology |
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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 |
| K813535 | XEROFORM DRESSING | Feb 4, 1982 | 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 |