FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLD/HOT PACK
K Number: K803299
·
Decision Jan 15, 1981
Classifications
1
FEI Numbers
467
Registration Numbers
468
Same Product Code
26
Applicant Total
7
Review Days
16
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Basic Information
- Device Name
- COLD/HOT PACK
- K Number
- K803299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5700
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- W.G. Whitney Corp.
- Date Received
- December 30, 1980
- Decision Date
- January 15, 1981
- Product Code
- IME
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IME | Pack, Hot Or Cold, Reusable | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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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 |
| 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 |